Force modulating tissue bridges, associated tools, kits, and methods

ABSTRACT

Force modulating tissue bridges, and associated applicators, kits and methods are provided. A force modulating tissue bridge can be a medical article for at least partially covering a wound and/or scar tissue. The medical article can include an elastic arch extending over an area, and a medial strut connected to the arch and extending into the area over which the central section extends.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2017/057569 filed Oct. 20, 2017, which claims the benefit of U.S.Provisional Application No. 62/411,023, filed Oct. 21, 2016. Each of theabove-referenced applications is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention generally relates to medical articles for coveringwounds and/or scars, and, more particularly, to wound closure and/orreducing wound tension.

BACKGROUND

Traditional methods of wound closure typically do not adequately controlwound tension, which is well known to be a primary stimulus of excessscar formation. In addition, tension reduction is known to decrease thesize, discoloration, and poor appearance of scars when applied duringthe wound healing period.

Therefore, a need exists for force modulating tissue bridges that seekto allow wounds to be closed accurately, and further seeks to providesimultaneous reduction of tension on closed wounds and scars in thehealing phases.

SUMMARY

An aspect of this disclosure is the provision of a medical article forat least partially covering a wound and/or scar tissue. The medicalarticle can include a body comprising a central section extending overan area, and flanges respectively extending outwardly from oppositelower sections of the central section. At least the central section ofthe body can be elastically configured to be deformed from an at restconfiguration to an extended configuration, so that at least the centralsection can return toward the at rest configuration in response to beingreleased from the extended configuration. The lower sections aretypically farther apart from one another in the extended configurationthan in the at rest configuration. A first of the flanges can haveopposite upper and lower surfaces that are each larger than a thicknessdefined between the upper and lower surfaces of the first flange. Themedical article can further include a foot pad connected to the firstflange for at least partially moving with the first flange. The foot padcan extend inwardly into the area over which the central sectionextends. The foot pad can have opposite upper and lower surfaces thatare each larger than a thickness defined between the upper and lowersurfaces of the foot pad. The upper surface of the foot pad and thelower surface of the first flange can face toward one another.

The central section can comprise an arch extending over the area overwhich the central section extends. The foot pad can be a first foot pad.A second of the flanges can have opposite upper and lower surfaces thatare each larger than a thickness defined between the upper and lowersurfaces of the second flange. The medical article can further comprisea second foot pad connected to the second flange for at least partiallymoving with the second flange. The second foot pad can extend inwardlyinto the area over which the central section extends. The second footpad can have opposite upper and lower surfaces that are each larger thana thickness defined between the upper and lower surfaces of the secondfoot pad. The upper surface of the second foot pad and the lower surfaceof the second flange can face toward one another.

The body can be stiffer than at least one of the foot pads. At least oneof the foot pads can include an extension (e.g., strut) extendinginwardly into the area over which the central section extends. At leastone of the foot pads can comprise an outer sheet configured to beattached to a patient's tissue, and an inner sheet positioned betweenthe outer sheet and the first flange, wherein the inner sheet can bestiffer than the outer sheet. The outer sheet can be larger than theinner sheet. An extension of the outer sheet can extend outwardly pastan outer edge of the inner sheet.

In accordance with another aspect of this disclosure, a medical articlecomprises an arch extending over an area, and a medial strut connectedto the arch and extending into the area over which the arch extends.Optionally, the medial strut can comprise an outer layer configured tobe attached to a patient's tissue, and an inner layer positioned betweenthe outer layer and the arch. Optionally, the inner layer can be stifferthan the outer layer, or vise versa. The medial strut can be a firstmedial strut. A second medial strut can be connected to the arch andextend into the area over which the arch extends. The first and secondmedial struts can be positioned oppositely with respect to one another.

A medical article optionally can further comprise, or otherwise beassociated with, at least one release liner adhered to the foot pad(s)and/or medial strut(s). A medical article optionally can include one ormore features (e.g., a hole, receptacle, space between the body and atleast a portion of a foot pad, and/or a catch part) configured forinteracting with an applicator tool.

Another aspect of this disclosure is the provision of a tool configuredfor being used to manipulate a medical article. The tool can comprisefirst and second parts that are spaced apart from one another and eachconfigured to releasably engage a medical article, a reconfigurablelinkage connecting the first and second parts to one another, and levers(e.g., handles) extending from proximate the linkage. The linkage andlevers can be cooperatively configured so that at least portions thefirst and second parts are moved away from one another in response to atleast portions of the levers being moved toward one another.

The first and second parts can be first and second catch partsconfigured to releasably attach to the medical article. Each of thecatch parts can comprise a shank and one or more protrusion extendingoutwardly from the shank. The tool optionally can further include abearing surface that is: positioned between the first and second catchparts, connected to the first and second catch parts by the linkage, andoptionally configured to engage the medical article while the first andsecond catch parts are engaged to the medical article.

In another aspect of this disclosure, a tool configured for being usedto manipulate a medical article can comprise a reconfigurable linkageconnecting first and second bodies to one another. The first body cancomprise a first lever connected to a first part. The second body cancomprise a second lever connected to a second part. The first and secondparts can be configured to respectively engage (e.g., at least partiallyreceive) opposite first and second ends of a medical article. Thereconfigurable linkage can be configured so that: the first and secondbodies are pivotable relative to one another about first and secondaxes, respectively, and the first and second axes are movable toward andaway from one another.

An aspect of this disclosure is the provision of a package having asupport comprising a central section and outer sections respectivelyextending outwardly and downwardly. A medical article can be at leastpartially supported by the support. Foot pads of the medical article canrespectively be proximate the outer sections of the support. One or moregaps between the support and the medial article can be configured toreceive a portion of a tool configured for being used to manipulate amedical article.

A liner can be positioned between the support and the medical article.The medical article can be releasably mounted to the liner. At least aportion of the liner can be fixedly mounted to the support. The linercan comprise a line of disruption for at least partially facilitatingrelative movement between the medical article and the support. The lineof disruption can at least partially define a flap in the liner. Suchflaps can be respectively associated with foot pads of the medicalarticle(s).

An aspect of this disclosure is the provision of a method for at leastdeforming a medical article from an at rest configuration to an extendedconfiguration. The deforming can be comprised of reconfiguring a toolwhile the tool and the medical article are engaged to one another. Thetool and the medical article being engaged to one another can becomprised of a first part of the tool and a first part of the medicalarticle being in engagement with one another, and a second part of thetool and a second part of the medical article being in engagement withone another. The reconfiguring of the tool can be comprised of movinglevers of the tool toward one another so that the first and second partsof the tool move away from one another in response to the moving of thelevers of the tool toward one another, and the first and second parts ofthe medical article move away from one another in response to the firstand second parts of the tool moving away from one another.

In accordance with an aspect of this disclosure, a method comprisesdeforming a medical article from an at rest configuration to an extendedconfiguration so that foot pads of the medical article are farther apartfrom one another in the extended configuration than in the at restconfiguration. Each of the foot pads can comprise an inner portion(e.g., medial strut) extending inwardly from an outer portion of thefoot pad, so that the inner portions are positioned between the outerportions of the foot pads. The inner portions can be adhesively mountedto a patient's tissue while the medical device is in its extendedconfiguration. Then the medial article can reconfigure from the extendedconfiguration to an intermediate configuration that is between the atrest configuration and the extended configuration. The outer portions ofthe pads can be adhesively mounted to the tissue while the medicaldevice is in its intermediate configuration. Optionally, the adhesivelymounting of the outer portions of the pads to the tissue can occur atleast partially in response to the automatic/biased reconfiguring of themedial article.

The foregoing summary provides a few brief examples and is notexhaustive, and the present invention is not limited to the foregoingexamples. The foregoing examples, as well as other examples, are furtherexplained in the following detailed description with reference toaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A through 1D depict various views of a medical article that mayoptionally be referred to as a force modulating tissue bridge, or simplytissue bridge, and which may be used to at least partially cover a woundand/or scar, for example to help facilitate wound closure and/or reducewound tension, in accordance with a first embodiment of this disclosure.

FIG. 1E is a pictorial exploded view of the tissue bridge of FIGS.1A-1D, wherein FIG. 1E further depicts the tissue bridge exploded awayfrom a schematically depicted section of a release liner and associatedadhesive material, in accordance with the first embodiment.

FIGS. 2A through 2D depict various views of a tool configured for beingused to manipulate the medical article or tissue bridge of FIGS. 1A-1E,wherein the tool may optionally be referred to as an applicator tool, inaccordance with the first embodiment.

FIG. 2E is a pictorial view of the applicator tool of FIGS. 2A-2Dmounted to the tissue bridge of FIGS. 1A-1E, in accordance with thefirst embodiment.

FIG. 3A is a top pictorial view of at least a portion of a kit orpackage comprising the applicator tool of FIGS. 2A-2D and several of thetissue bridges of FIGS. 1A-1E at least partially contained in a tray, inaccordance with the first embodiment.

FIG. 3B is a partially exploded view of some of the objects of thepackage of FIG. 3A, in accordance with the first embodiment.

FIG. 3C is an isolated, top plan view of the tray of FIG. 3A, inaccordance with the first embodiment.

FIG. 3D is a top plan view of the tray of FIG. 3A containing theapplicator tool and release liner, in accordance with the firstembodiment.

FIG. 3E is a top plan view of the package of FIG. 3A, in accordance withthe first embodiment.

FIGS. 4A through 4F depict a sequence of steps of a method of using theapplicator tool to remove a tissue bridge from the tray, in accordancewith the first embodiment.

FIGS. 4G through 4K depict a sequence of steps of a method of using theapplicator tool to apply the tissue bridge to a wound, in accordancewith the first embodiment.

FIGS. 5A through 5D depict various views of a medical article or tissuebridge having a central release liner and release liner mounting strapsaffixed thereto, in accordance with a second embodiment of thisdisclosure.

FIGS. 6A through 6F depict a sequence of steps of a method of applyingthe tissue bridge of FIGS. 5A-5D to a wound, in accordance with thesecond embodiment.

FIG. 7 depicts a step of a method of applying the tissue bridge to awound, in accordance with a third embodiment of this disclosure.

FIG. 8A is an isolated, pictorial view of an applicator tool, inaccordance with a fourth embodiment of this disclosure.

FIG. 8B is a pictorial view of the applicator tool of FIG. 8A mounted toa tissue bridge, in accordance with the fourth embodiment.

FIG. 8C depicts a step of a method of applying the tissue bridge to awound, in accordance with the fourth embodiment.

FIG. 9A is an isolated, pictorial view of an applicator tool, inaccordance with a fifth embodiment of this disclosure.

FIG. 9B is a pictorial view of the applicator tool of FIG. 9A mounted toa tissue bridge, in accordance with the fifth embodiment.

FIGS. 9C and 9D depict a step of a method of applying the tissue bridgeto a wound, in accordance with the fifth embodiment.

FIG. 10A is a pictorial view of a tissue bridge, in accordance with asixth embodiment of this disclosure.

FIGS. 10B and 10C depict an applicator tool mounted to the tissue bridgeof FIG. 10A, in accordance with the sixth embodiment.

FIGS. 10D and 10E depict a step of a method of applying the tissuebridge to a wound, in accordance with the sixth embodiment.

FIG. 11A is a pictorial view of a tissue bridge, in accordance with aseventh embodiment of this disclosure.

FIGS. 11B and 11C depict an applicator tool mounted to the tissue bridgeof FIG. 11A, in accordance with the seventh embodiment.

FIGS. 11D and 11E depict a step of a method of applying the tissuebridge to a wound, in accordance with the seventh embodiment.

FIGS. 12A and 12B depict an applicator tool mounted to a tissue bridge,in accordance with an eighth embodiment.

FIGS. 12C and 12D depict a step of a method of applying the tissuebridge to a wound, in accordance with the eighth embodiment.

FIGS. 13A and 13B depict a tissue bridge, in accordance with a ninthembodiment.

FIG. 13C is an exploded view of the tissue bridge, in accordance withthe ninth embodiment.

FIG. 13D is a cross-sectional view of at least a portion of a kit orpackage comprising the tissue bridge at least partially contained in atray, in accordance with the ninth embodiment.

FIGS. 13E and 13F depict a sequence of steps of a method of using anapplicator tool to remove a tissue bridge from the tray, in accordancewith the ninth embodiment.

FIG. 14 is a bottom pictorial view of an applicator tool, in accordancewith a tenth embodiment.

FIG. 15 is a top plan view of a tray at least partially containing theapplicator tool and a series of tissue bridges, in accordance with thetenth embodiment.

FIG. 16A is a schematic top plan view of an elongate scar or wound intissue.

FIG. 16B is like FIG. 16A, except that the scar or wound is covered by astrip.

FIG. 16C is like FIG. 16B, except that tissue bridges have been mountedover the strip, in accordance with an embodiment of this disclosure.

FIG. 16D is a side elevation view of a first version of the assembly of16C.

FIG. 16E is a side elevation view of a second version of the assembly ofFIG. 16D, and FIG. 16E also depicts a tissue bridge in accordance withanother embodiment of this disclosure.

FIG. 16F is similar to FIG. 16E, in accordance with another embodimentof this disclosure.

FIG. 16G is a side elevation view of a tissue bridge in accordance withan embodiment of this disclosure.

FIGS. 17A through 17C depict a tissue bridge in accordance with aneleventh embodiment.

FIG. 17D is a cross-sectional view taken along line 17D-17D of FIG. 17B.

FIG. 17E is an end elevation view of the tissue bridge of the eleventhembodiment.

FIG. 17F is a top pictorial exploded view of the tissue bridge of theeleventh embodiment, wherein FIG. 17F further depicts the tissue bridgeexploded away from a schematically depicted section of a release linerand associated adhesive material, in accordance with the eleventhembodiment.

FIG. 17G is a bottom pictorial exploded view of selected layers of thetissue bridge of the eleventh embodiment

FIGS. 18A through 18C depict various views of an applicator tool inaccordance with the eleventh embodiment.

FIG. 18D depicts the applicator tool mated to a tissue bridge of apackage including a tray and series of tissue bridges, in accordancewith the eleventh embodiment.

FIGS. 19A through 19F depict a sequence of steps of a method of usingthe applicator tool to remove a tissue bridge from the tray, inaccordance with the eleventh embodiment.

FIGS. 19G and 19H depict different confirmations of a release linerassociated with a tissue bridge and tray, in accordance with theeleventh embodiment.

FIGS. 19I through 19L depict a sequence of steps of a method of usingthe applicator tool to apply the tissue bridge to a wound, in accordancewith the eleventh embodiment.

FIG. 20A is top plan view of a tissue bridge of a variation of theeleventh embodiment.

FIG. 20B is an isolated, top plan view of a footpad of the tissue bridgeof the variation of the eleventh embodiment.

FIG. 20C is an end elevation view of the tissue bridge of the variationof the eleventh embodiment.

FIG. 20D is a top pictorial exploded view of the tissue bridge of thevariation of the eleventh embodiment, wherein FIG. 20D further depictsthe tissue bridge exploded away from a section of a release liner, inaccordance with the variation of the eleventh embodiment.

FIG. 21 depicts a variation of the applicator tool of the eleventhembodiment.

FIG. 22 depicts another variation of the applicator tool of the eleventhembodiment.

FIGS. 23A through 23C depict an applicator tool in accordance with atwelfth embodiment.

FIGS. 24A through 24C depict an applicator tool in accordance with athirteenth embodiment.

FIGS. 25A through 25C depict an applicator tool in combination with atissue bridge, in accordance with a fourteenth embodiment.

FIGS. 26A through 26C depict an applicator tool in combination with atissue bridge, in accordance with a variation of the fourteenthembodiment.

FIGS. 27A and 27B depict an applicator tool in combination with a tissuebridge, in accordance with a variation of the fourteenth embodiment.

FIGS. 28A and 28B depict an applicator tool in combination with a tissuebridge, an in accordance with a variation of the fourteenth embodiment.

FIGS. 28D through 28E depict a sequence of steps of a method of usingthe applicator tool to apply the tissue bridge to a wound, in accordancewith the fourteenth embodiment.

FIGS. 29A through 29C are top plan views of trays including mountingfeatures, in accordance with other embodiments of this disclosure.

FIG. 30 depicts a tray that is carrying a series of tissue bridges, andis equipped with fastening straps, in accordance with an embodiment ofthis disclosure.

FIG. 31 depicts the tray with tissue bridges of FIG. 30 mounted on thearm of a user, in accordance with an embodiment of this disclosure.

FIG. 32 depicts the tray with tissue bridges of FIG. 30 with thefastening straps removed, wherein the tray is exploded away from amounting base, in accordance with an embodiment of this disclosure.

FIG. 33 depicts a tray that is carrying a series of tissue bridges, andis equipped with fastening straps, in accordance with an embodiment ofthis disclosure.

FIG. 34 depicts a tray with tissue bridges exploded away from a mountingbase equipped with clips and fastening straps, in accordance with anembodiment of this disclosure.

FIG. 35 depicts a tray with tissue bridges exploded away from a mountingbase equipped with adhesive material and fastening straps, in accordancewith an embodiment of this disclosure.

DETAILED DESCRIPTION

Numerous embodiments are described below and illustrated in theaccompanying figures, in which like numerals refer to like partsthroughout the several views. For convenience of description and ease ofunderstanding, and not for the purpose of limiting the scope of thisdisclosure or the associated inventions, some embodiments may bereferred to by number. The embodiments described provide examples andshould not be interpreted as limiting the scope of the invention. Otherembodiments, and modifications and improvements of the describedembodiments, will occur to those skilled in the art and all such otherembodiments, modifications and improvements are within the scope of theinvention.

FIGS. 1A-1D depict an at least partially elastic (e.g., generallyelastic) medical article 20 in its undeformed or at rest configuration(e.g., relaxed state), in accordance with a first embodiment. Themedical article 20 may optionally be referred to as a force modulatingtissue bridge 20, or simply tissue bridge 20, and throughout thisdisclosure the tissue bridge may be more generally referred to as amedical article. In the following, first an example of a method of usingthe tissue bridge 20 is very briefly described, and thereafter thetissue bridge and other aspects of this disclosure are described ingreater detail.

The tissue bridge 20 can be mounted to tissue such as, but not limitedto, a surface of a patient's skin, for example the outer surface of thepatient's epidermis. The tissue bridge 20 is typically mounted so thatit extends across and at least partially covers a wound and/or scar. Inthe first embodiment, the tissue bridge 20 comprises generally elasticmaterial, and prior to the tissue bridge being mounted on the patient,the tissue bridge can be generally elastically deformed from itsundeformed or at rest configuration to a strained, deformed, or extendedconfiguration. The tissue bridge 20 can at least begin to be mounted tothe tissue (e.g., skin tissue), so that a central section of the tissuebridge extends across a wound and/or scar, while the tissue bridge ismaintained in its extended configuration. After being at least partiallymounted in its extended configuration, the tissue bridge 20 can beallowed to generally elastically reconfigure from its extendedconfiguration at least partially toward its at rest configuration, whichmay, for example, reduce tension in the tissue, help close the wound,help inhibit wound reopening, and/or inhibit scar disfiguring (e.g.,widening), as will be discussed in greater detail below. In the firstembodiment, the tissue bridge 20 comprises material that is at leastgenerally elastic, so that the tissue bridge is biased toward its atrest configuration (e.g., relaxed state).

The tissue bridge 20 of the first embodiment comprises a generallyelastic body 22 and one or more multi-layer foot pads 24 mounted to thebody, although in some examples one or more of the foot pads and/orportions thereof can be omitted (e.g., a foot-pad may consist of, orconsist essentially of, a single layer). The body 22 can be generallyreferred to as and/or generally function as a backbone or other suitablestructure configured to movably connect two or more of the foot pads 24to one another. In the embodiment shown in FIGS. 1A-1E, the body 22includes at least two flanges 26 (e.g., feet) respectively extendingobliquely, for example outwardly and downwardly, from opposite lowerportions of a central section or arch 28 of the body. Each of theflanges 26 can be planar, or they can be substantially or about planarsince it may not be critical that the flanges be exactly planar. Theflanges 26 can extend divergently relative to one another, and obliquelyrelative to one another. The arch 28 can include a central spanningsection 30, and lower sections 32 respectively extending downwardly fromopposite portions of the spanning section. The lower sections 32 of thearch 28 can optionally be configured as and/or referred to as shoulders32. The flanges 26 can respectively extend obliquely, for exampleoutwardly and downwardly, from lower portions of the shoulders 32. Theshoulders 32 can provide a smoothly curved transition between thespanning section 30 of the arch 28 and the flanges 26. In the embodimentshown in FIGS. 1A-1E, the spanning section 30 of the arch 28 has arelatively low profile and is at least generally arcuate, which can beadvantageous for an active person having the tissue bridge 20 mounted ontheir skin. Alternatively, it is believed that in some situations thearch 28 can be at least more of a flat arch, or the spanning section 30of the arch can be flat, or the arch or features thereof can be in anyother suitable configurations that will allow the tissue bridge 20 tofunction generally or substantially as described herein.

Each of the parts of the tissue bridge 20 will typically be constructedof suitable medical-grade materials. For example, the body 22 can be aninjection-molded or mechanically thermoformed, unitary (e.g.,single-piece) article such that the spanning section 30, shoulders 32and flanges 26 can be formed together as a single article from aninjection-moldable or formable, generally elastic material such as, butnot limited to, polycarbonate, or any other suitable injection-moldableor formable material. Referring to FIG. 1C, each of the spanning section30, shoulders 32, and flanges 26 can be about the same thickness, oralternatively the thickness of the body 22 can vary along its length.Referring to FIG. 1B, the width of the body 22 can, for example, taperalong its length, so that the spanning section 30 is relatively narrow(e.g., has a narrowed waist) as compared to the shoulder 32 and flanges26, so that the spanning section can be more readily deformed ascompared to the shoulders and flanges. For example, the side edges ofthe spanning section 30 can be inwardly curved or concave, as shown inFIGS. 1A, 1B and 1D, or they may have a stepped or other suitableconfigurations. Alternatively, the side edges of the spanning section 30can extend generally or substantially straight in a top plan view of thetissue bridge 20, or they can extend in any other suitable manner.

As shown in FIGS. 1A-1D, the foot pads 24 can be spaced apart from oneanother, and the foot pads can be fixedly mounted to the flanges 26.Each foot pad 24 can be or include be a mat, laminate or other suitablestructure comprising one or more layers of material. For example, in thefirst embodiment, each foot pad 24 includes an outer layer or sheet 34configured to be attached to tissue (e.g., skin tissue), and an innerlayer or sheet 36 positioned between, and fixedly connected to each of,the outer sheet 34 and the respective flange 26.

Referring to the exploded view of FIG. 1E, the tissue bridge 20 caninclude inner, intermediate and outer adhesive layers 38, 40, 42. Theinner adhesive layers 38 can be between and fixedly connect the innersheets 36 to the flanges 26, the intermediate adhesive layers 40 can bebetween and fixedly connect the outer sheets 34 to the inner sheets, andthe outer adhesive layers 42 can be on the outer sides of the outersheets for attaching the tissue bridge 20 to tissue (e.g., a patient'sskin), as will be discussed in greater detail below.

The outer and inner sheets 34, 36 can be provided, for example, by diecutting them from appropriate webs or larger sheets of material, such asfabric or cast microporous polymeric sheet for the outer sheets 34, andan extruded polymer or plastic sheet for the inner sheets 36. The outersheets 34 can be made of suitable fabric materials, cast materials,films, or other materials of the type from which skin-contact layers ofbandages or other wound dressings are formed, or any other suitablematerial. The plastic inner sheets 36 can be made of suitable materialssuch as, for example, polyethylene, polyethylene terephthalate, or anyother suitable materials. The inner and intermediate adhesive layers 38,40 can respectively comprise adhesive materials that are compatible withthe materials being connected thereby. The outer adhesive layer 42(e.g., patient contact adhesive) can be, for example, adhesive materialof the type that is typically used as an adhesive backing for bandagesor other wound dressings. In the first embodiment, the outer adhesivelayer 42 can have a lower adhesive strength than the inner andintermediate adhesive layers 38, 40, such as when the tissue bridge 20is to be removably mounted to tissue (e.g., a patient's skin).

In the first embodiment, both the body 22 and the inner sheet 36 have ahigher modulus of elasticity (e.g., are formed from stiffer material)than the outer sheet 34. More generally, the body 22 and the inner sheet36 can be stiffer than the outer sheet 34 because of a variety offactors, such as being larger, thicker, comprising material having ahigher modulus of elasticity and/or being constructed to have anapparent modulus of elasticity. Similarly, the body 22 can have a highermodulus of elasticity than the foot pads 24.

As shown in FIG. 1C, the body 22, including its flanges 26, can bethicker than each of the outer and inner sheets 34, 36, and the arch 28can extend over an area into which portions of the outer and innersheets can optionally extend. The area over which the arch 28 extendsmay be referred to as a central area, a treatment area, an under-archarea, and/or the like. The thicknesses of the body 22 and sheets 34, 36can be varied, for example, independently as necessary to produce tissuebridges 20 of different sizes and to function optimally in differentanatomical areas and with different treatment tissue characteristics.

As shown in FIGS. 1A and 1E, at each end of the tissue bridge 20, theflange 26, outer sheet 34, inner sheet 36, and adhesive layers 38, 40,42 can be at least partially superposed with one another and can havedifferent configurations from one another. For example and asschematically illustrated in FIG. 1E by dashed boundary lines on theouter and inner sheets 34, 36, a congruent portion 44 of each innersheet can be superposed with and coextensive with the respective flange26, and a congruent portion 46 of the outer sheet 34 can be superposedwith and coextensive with the respective inner sheet congruent portion44. As other examples that are also at least partially schematicallyillustrated by the dashed boundary lines in FIG. 1E, inner extensions 48of the outer and inner sheets 34, 36 can extend congruently with oneanother into the central area over which the arch 28 extends such thatthe inner extensions 48 are neither superposed by nor coextensive withthe flanges 26. More generally, each foot pad 24 can include at leastone extension 48 that extends into the central area over which the arch28 extends such that the inner extension 48 can be neither superposed bynor coextensive with the flanges 26.

In the first embodiment, the inner extensions 48 may be referred to asmedial extensions 48, for example since they extend toward the middle ofthe area over which the arch 28 extends. As another example and as willbe discussed in greater detail below, the inner or medial extensions 48can be configured so that they at least partially resist longitudinalcompression when the tissue bridge 20 in its extended configuration ismounted to tissue (e.g., skin tissue) and then allowed to generallyelastically reconfigure from its extended configuration at leastpartially toward its at rest configuration. Accordingly, the inner ormedial extensions 48 can be referred to as medial struts 48. In thefirst embodiment, each medial strut 48 includes the inner extensions 48of both sheets 34, 36, but one or more layers or sheets of the medialstrut 48 can be omitted, such that each medial strut can be formed ofone or more layers of material.

Referring to FIGS. 1A and 1E, one or more outer extensions 50 of thefoot pads 24, or more specifically of the outer sheets 34, can extendoutwardly such that they are neither superposed by nor coextensive withthe flanges 26 or the medial struts 48. In the example shown in FIG. 1B,outer extensions 50 can extend outwardly past one or more of theperipheral edges (e.g., the outer end edges and side edges) of theflanges 26.

In the example shown in FIG. 1C, the medial struts 48 can be spacedapart from (e.g., at least partially spaced apart from) the arch 28 andextend into the central area over which the arch extends, so that gapsor receptacles 52 are at least partially defined between the medialstruts and the arch. The receptacles 52 can at least partially define,or be at least part of, catch parts configured for interacting withcorresponding features of an applicator tool that may be used, forexample, in the mounting of the tissue bridge 20 to tissue (e.g., apatient's skin), wherein the applicator tool is discussed in greaterdetail below. For example, the tissue bridge 20 can include one or morecatch parts, and the catch parts can respectively comprise thereceptacles 52. A variety of differently configured catch parts arewithin the scope of this disclosure.

In the first embodiment, the body 22 includes at least two catch partsthat further comprise holes 56 that extend through the body 22 and areopen to the receptacles 52. The holes 56 can be defined in the arch 28,or more specifically the holes can be positioned in opposite endportions of the spanning section 30. In the example shown in FIG. 1B,the holes 56 can be open to the central area over which the arch 28extends, or more specifically the holes can be open to the receptacles52; and the medial struts 48 can extend beneath the holes.

As shown in FIGS. 1A and 1B, each of the holes 56 can be triangular,with a side of the triangle, or more specifically an edge 58 of the arch28 that defines the triangle, extending crosswise to the length of thearch. The respective catch part can further include the edge 58. Theedge 58 can extend parallel, or more generally substantially parallel orabout parallel, to the boundary between the spanning section 30 and therespective shoulder 32. In other words, the edge can extendperpendicular to, or more generally substantially perpendicular to orabout perpendicular to, the lengthwise or longitudinal axis of the body22. In addition, the holes 56, when present, can reduce the area orvolume of the outer portions of the spanning section 30 in a manner thatenhances the deformability of the outer portions of the spanningsection.

Each catch part can further include a portion 60 (FIG. 1C) of the lowersurface of the arch 28, wherein the surface portion 60 extends outwardlyfrom the edge 58. The catch parts, receptacles 52, holes 56 andassociated edges 58, and surface portions 60, or the like, may beoptional, and other positions and configurations of catch parts,receptacles, holes, or the like, are within the scope of thisdisclosure.

In a version of the first embodiment, the foot pads 24 can be describedas including the flanges 26, so that the flanges can be respectivelayers of the foot pads, and the flanges can be referred to as footplates 26, or the like. As another example, the first embodimentembraces configurations of the tissue bridge 20 in which the foot plates26 are not integrally formed with the arch 28. For example, the footplates 26 can be formed separately from the arch 28 and can be fixedlyor movably connected to the arch, such as by way of pivots, hinges, orany other suitable features. Other variations are also with the scope ofthis disclosure. For example, the foot plates 26 can have one or moreholes formed therein or therethrough, as discussed in greater detailbelow. As another example alluded to above, one or more layers of eachfoot pad 24 can be omitted. For example and for each foot plate 26, itmay be suitable in some situations to omit the layers between the footplate and outer adhesive layer 42, so that the outer adhesive layer,which is for use in mounting the tissue bridge 20 to tissue (e.g., apatient's skin), is mounted directly to the underside of the foot plate.It is also within the scope of the first embodiment for the medialstruts 48 to be integrally formed with the arch 28, flanges 26 and/orfoot plates 26. For example, the medial struts 48 can be extensions ofthe flanges 26 and/or foot plates 26.

As alluded to above, FIG. 1E depicts the tissue bridge 20 in an explodedconfiguration. Additionally, FIG. 1E depicts the tissue bridge 20exploded away from a schematically depicted section of a release liner62 and associated adhesive material 64. As an example, after a tissuebridge 20 is manufactured or as part of the manufacturing process forthe tissue bridge, the tissue bridge, or more specifically the outersheets 34 by way of the outer adhesive layers 42, can be releasablymounted on the upper surface of the release liner 62. In addition, thelower surface of a portion of the release liner 62 can be fixedlymounted to a support by way of the adhesive material 64, as will bediscussed in greater detail below. The release liner 62 can be, forexample, a paper or plastic-based film sheet coated with a release agentthat is engaged against the outer adhesive layers 42 so that the tissuebridge 20 is releasably mounted on the release liner.

In accordance with the first embodiment, the tissue bridge 20 can be atleast somewhat translucent, and the tissue bridge can optionally includeindicia, visible design elements and/or other visual features comprisingone or more of color, contrasting colors, decorations, aligning marks,pictures, logos, images, characters, words, or any other suitablefeatures that can be printed matter, or the like, wherein the printedmatter, or the like, can be embedded or encapsulated in the tissuebridge and visible through one or more exterior surfaces of the tissuebridge. For example, one or more of the components or layers of thetissue bridge 20 can be at least generally transparent and/or at leastgenerally translucent, and the printed matter, or the like, can beinterior of exterior surfaces of the tissue bridge 20 and seen by a userof the tissue bridge through at least one of the exterior surfaces ofthe tissue bridge. For example, the printed matter, or the like, can beon a layer or surface of the tissue bridge 20 that is internal to thetissue bridge (e.g., printed matter, or the like, can be positioned or“sandwiched” between the various layers of the tissue bridge). Referringto FIG. 1E and as an example, the body 22 and the inner sheets 36 caneach be at least partially transparent, and the printed matter, or thelike, can be on the top surface of at least one of the outer sheets 34so that it is visible through the body 22 and the respective inner sheet36. As another example, the body 22 can be at least partiallytransparent, and the printed matter, or the like, can be on the topsurface of at least one inner sheet 36 so that it is visible through thebody 22. Alternatively, it is believed that the printed matter, or thelike, can be contained in one of more of the adhesive layers 38, 40, 42and/or in any other suitable location, with the predetermined portion(s)of the tissue bridge 20 being least partially transparent and/ortranslucent for allowing the printed matter, or the like, to be visiblethrough one or more exterior surfaces of the tissue bridge.

FIGS. 2A-2D depict an applicator mechanism in the form of an applicatortool 80 that can be used, for example, to manipulate the tissue bridge20 or another suitable medical article, for example as part of a methodof mounting the tissue bridge to tissue (e.g., a patient's skin), inaccordance with the first embodiment. For example, the applicator tool80 can include one or more parts or features that can be spaced apartfrom one another and can be configured to releasably engage the tissuebridge 20. In the first embodiment, the one or more parts or features ofthe applicator tool 80 that are configured to engage the tissue bridge20 can comprise at least one bearing or contact surface 82 and/or one ormore catch parts 84. For example, the contact surface 82 can bepositioned between the catch parts 84. The applicator tool 80 canfurther include a reconfigurable frame connecting the contact surface 82and catch parts 84 to one another. The applicator tool 80, and the like,can be more generally referred to as a tool. For example, the tool 80,or the like, may be used for more purposes than applying a tissue bridge20.

The frame can include a reconfigurable linkage (e.g., one or more links86A, 86B) connecting the contact surface 82 and catch parts 84 to oneanother, and one or more levers 88A, 88B extending upwardly from thelinks 86A, 86B. The applicator tool 80 can be configured so that whenthe bearing or contact surface 82 faces downwardly, the catch parts 84extend downwardly from the linkage (e.g., link(s) 86A, 86B), and thelevers 88A, 88B extend upwardly from the linkage. The links 86A, 86B andthe levers 88A, 88B can be cooperatively configured so that at leastportions of the catch parts 84 move away from one another, and thecontact surface 82 moves toward a line between the catch parts 84, inresponse to at least portions of the levers 88A, 88B being moved towardone another, as will be discussed in greater detail below.

The links 86A, 86B can comprise several links, for example a centrallink 86A and outer links 86B. Similarly, the levers 88A, 88B cancomprise several levers, for example inner levers 88A and outer levers88B. In the example shown in FIGS. 2A-2D, the contact surface 82 can bea lower end face of the central link 86A, and the catch parts 84 caninclude shanks 90 extending from lower ends of the outer links 86Band/or outer levers 88B. Each catch part 84 can further include at leastone protrusion 92 extending outwardly from the lower end of the shank 90in a direction that is crosswise to the length of the shank. Theprotrusions 92 can face away from one another.

The outer links 86B can extend obliquely, outwardly and downwardly fromopposite sides of an upper portion of the central link 86A respectivelyto upper portions of the shanks 90. The inner levers 88A can extendobliquely, outwardly and upwardly from opposite sides of an upperportion of the central link 86A. The outer levers 88B can extendobliquely, outwardly and upwardly respectively from upper portions ofthe shanks 90.

The levers 88A, 88B can be configured as and/or comprise handles 94. Forexample, in the embodiment depicted in FIGS. 2A and 2B, a handle 94 caninclude adjacent levers 88A, 88B that are connected to one another.These connections can comprise the adjacent levers 88A, 88B beingdirectly connected to one another proximate their upper ends, andcrossmembers 96 connected to and spanning between the adjacent levers.

The applicator tool 80 can be an injection-molded, unitary (e.g.,single-piece) article formed from an injection-moldable, generallyelastic material such as, but not limited to, polycarbonate,polyethylene, or any other suitable injection-moldable material.Alternatively, the applicator tool 80 can be made of metal, metalalloys, steel, or any other suitable materials that can allow forre-sterilization. For example, hinges or other suitable connections thatallow for relative movements between subparts can be included in theapplicator tools 80, such as when the applicator tools are made ofrelatively rigid materials. As additional examples, a variety ofdifferent linkages, levers 88A, 88B, and handles 94 are within the scopeof this disclosure, as will be discussed in greater detail below.

In accordance with an example of the first embodiment depicted in FIG.2E, the tissue bridge 20 and applicator tool 80 are cooperativelyconfigured so that the applicator tool can be releasably engaged to thetissue bridge, and the applicator tool can be used to manipulate thetissue bridge as part of a method of mounting the tissue bridge totissue. For example, FIG. 2E depicts the bearing or contact surface 82in opposing-face-to-face relation with an upper surface of the arch 28,and the shanks 90 extending through the holes 56. In the configurationof FIG. 2E, the protrusions 92 are hidden from view within thereceptacles 52, as partially schematically illustrated by dashed lines.More generally, the above-discussed catch parts of the applicator tool80 and tissue bridge 20 are respectively engaged to one another in FIG.2E. However, a variety of differently configured catch parts are withinthe scope of this disclosure.

The applicator tool 80 can optionally further include one or morefeatures for at least partially facilitating predetermined cooperativeinteraction between the applicator tool and the tissue bridge 20. Forexample, the levers 88A, 88B and/or handles 94, or features associatedtherewith, can be configured to come into contact with one another whenthe desired degree of deformation is reached in the tissue bridge 20,thereby seeking to prevent over distortion of the tissue bridge. Inaddition or alternatively, the levers 88A, 88B and/or handles 94, orfeatures associated therewith, can be configured to (e.g., can includeone or more catches, rows of catches, or the like, configured to) causethe applicator tool 80 to hold the tissue bridge 20 in one or morepredetermined states of deformation (e.g., one or more predeterminedstrained, deformed, or extended configurations) without requiring theuser to continually squeeze together the handles 94, or the like. Forexample, the applicator tool 80 can include mechanisms (e.g. rows ofcatches) that can be sequentially activated, similarly to suchmechanisms of surgical clamps, so one click (e.g., a first predeterminedengagement between the catches or the like) can cause a relatively lowstate of deformation in the tissue bridge, two clicks (e.g., a secondpredetermined engagement between the catches or the like) can cause arelatively medium state of deformation in the tissue bridge, and threeclicks (e.g., a third predetermined engagement between the catches orthe like) can cause a relatively large state of deformation in thetissue bridge (e.g., the full deformation). In addition, the levers 88A,88B, handles 94 and/or other suitably associated features can havedifferent shapes to assist in ergonomically optimized use, for exampleby comprising partial or complete rings, recesses shaped to accept theuser's digit(s) and/or other suitable features. Cooperative interactionbetween the applicator tool 80 and tissue bridge 20, such as engagementbetween their catch parts, will be discussed in greater detail below,after a discussion of the option of the tissue bridges and applicatortools being conveniently provided as parts of kits.

In accordance with the first embodiment, and as at least partiallydepicted in FIG. 3A, one or more of the tissue bridges 20 and optionallyat least one applicator tool 80 can be provided as part of a kit orpackage 120 that can further include the release liner 62 and adhesivematerial 64 (FIG. 1E). In the example shown in FIGS. 3A-3C, the package120 can include a container in the form of an injection molded orvacuum-formed tray 122, or the like. The tray 122 can have a base panel124 and sidewalls 126 extending upwardly from the periphery of the basepanel to define a cavity of the tray. Also, the package 120 and/or tray122 can optionally include at least one divider 128 that extendsupwardly from the base panel 124 and is positioned between and distantfrom opposite sidewalls 126 to at least partially divide the tray cavityinto at least first and second compartments configured for respectivelyreceiving the applicator tool 80 and one or more tissue bridges 20. Thefirst compartment of the tray 122, or more specifically the divider 128and the sidewalls 126 that at least partially define the firstcompartment of the tray, can define a shape that is complementary to theperipheral shape of, and about the same size as, the applicator tool 80,so that a releasable interference fit can be defined between the firstcompartment and the applicator tool within the first compartment. Asanother example, the first compartment of the tray 122, divider 128 andapplicator tool 80 can be omitted from the tray 122. Any applicator tool80 can be provided as part of a package that is separate from thepackage including the tray 122.

As an example, the tray 122 can be an inner tray that can be put ineither an outer tray, a pouch and/or other suitable packaging. As otherexamples, the tray 122 can include other features, for example slots orother surface features that can be used to secure the tray to the user'sbody (e.g., non-dominant forearm), to a fixture (e.g., a mayo tray), orin other suitable configurations.

Referring to the exploded view of FIG. 3B, and the isolated top planview of the tray 122 in FIG. 3C, the base panel 124 can be configured inthe form of and/or to define a generally ridge-shaped support extendingalong at least a portion of the length of the tray. The ridge-shapedsupport can include an elevated central section 130 of the base paneland downwardly sloping outer sections 132 of the base panel. The centralsection 130 can be flat, although exact flatness may not be requiredsuch that the central section can be generally or substantially flat, orin any other suitable configuration. For example, the central sectioncan be concave, or the like. The outer sections 132 can extendobliquely, or more specifically outwardly and downwardly, from oppositeportions or edges of the raised central section 130. For example, theouter sections 132 can extend obliquely, inwardly and upwardly fromlower, marginal portions 134 of the base panel 124. Two or more pairs ofouter sections 132 can be included in each tray 122. Alternatively, thecentral section 130 can be recessed downwardly relative to innerportions of the outer sections 132.

Referring to FIGS. 1E, 3A, 3B, 3D and 3E, the release liner 62 caninclude a series of lines of disruption 136. Each line of disruption 136can comprise one or more cuts, slits, breachable lines of disruption,perforations and/or overlapping and/or sequential combinations thereof,for at least partially defining flaps 138 in the release liner 62, aswill be discussed in greater detail below. The lines of disruption 136can be configured in a variety of patterns. In some examples, thepattern may be symmetrical in relationship to each associated (e.g.,subsequently mounted) tissue bridge 20. In other examples, the lines ofdisruption 136 can be asymmetrical in relationship to each associated(e.g., subsequently mounted) tissue bridge 20. In the first embodiment,each line of disruption 136 extends partially around the foot pad 24that is mounted to the flap 138 defined by the line of disruption, andopposite ends of the line of disruption extend beneath the food pad.

In accordance with the first embodiment, the tissue bridges 20 can bemanually assembled and/or at least partially assembled by way of one ormore automated coating, laminating and cutting processes. For example,the release liner 62 can be a base ply or layer of a laminate that isappropriately cut (e.g., die cut) and partially delaminated to at leastpartially form the foot pads 24 on the release liner, and thereafter thebodies 22 can be respectively mounted to the foot pads 24, or the like.The lines of disruption 136 can be formed by an appropriate one or moreof the cutting (e.g., die cutting) steps, or the like, such that thelines of disruption (e.g., slits, perforations or other suitable cuts)may extend at least partially into one or more layers of the foot pad24. As a more specific example, the lines of disruption 136, orextensions thereof, or the like, may extend into the outer adhesivelayer 40 (FIG. 1E). At an appropriate time, typically after the diecutting, or the like, the underside of the release liner 62 can befixedly secured to the surface of the outer sections 132 of the tray 122by way of, for example, adhesive material 64 (FIG. 1E) arranged in apattern such that the adhesive material is omitted from between theflaps 138 in the release liner and the respective portions (e.g., outersections 132) of the tray, so that the flaps can be moved relative tothe reminder of the release liner, as will be discussed in greaterdetail below. More generally, any adhesion or other suitable connectionbetween the flaps 138 and the respective portions (e.g., outer sections132) of the tray 122 is weaker than the adhesion or other suitableconnection between the remainder of the release liner 62 and the tray,so that the flaps can be moved relative to the reminder of the releaseliner, as will be discussed in greater detail below.

Referring to FIGS. 4A-4F, a method of using the applicator tool 80 toremove a tissue bridge 20 from the tray 122 is described in thefollowing, in accordance with the first embodiment. In FIGS. 4A-4F, thetray 122 and release liner 62 are cross-sectioned along line 4-4 of FIG.3E. Referring to FIG. 4A, initially, the applicator tool 80 (e.g., inits undeformed or at rest configuration) can be engaged against thetissue bridge 20 (e.g., in its undeformed or at rest configuration) byway of relative movement causing increased closeness between theapplicator tool 80 and the tray 122 (e.g., movement of the applicatortool toward the tissue bridge mounted on the release liner 62 in thetray). Referring to FIGS. 4A and 4B, in response to the relativemovement, the protrusions 92 of the tool catch parts 84 can enter thereceptacles 52 by way of the holes 56 (FIGS. 1A and 1B). That is, theprotrusions 92 can enter the receptacles 52 by traveling through theholes 56. For example, the applicator tool 80 can be pushed downwardlyto engage the tissue bridge 20 in a manner so that the protrusions 92 ofthe tool catch parts 84 enter the receptacles 52 by way of the holes 56,and optionally also the tool contact surface 82 engages the central apexor any other suitable surface of the arch 28. The applicator tool 80 canbe in its undeformed or at rest configuration throughout the step of theprotrusions 92 of the tool catch parts 84 entering the receptacles 52 byway of the holes 56. As another example, the distance between the tipsof the protrusions 92 can be greater than the distance between the holeedges 58 (FIGS. 1A and 1B) so that the protrusions “snap” into the holes56 and/or receptacles 52 and are optionally releasably contained in thereceptacles by way of an interference fit, or the like.

The relative movement causing increased closeness between the applicatortool 80 and the tray 122 may be facilitated by a user manually holdingthe handles 94 of the applicator tool and moving the applicator tooltoward the tissue bridge 20 in the tray, or the tissue bridge may besupported by any other suitable surface. Referring to FIG. 4B, theprotrusions 92 can engage respective surfaces of the medial struts 48 inresponse to the relative movement causing increased closeness betweenthe applicator tool 80 and the tray 122.

For serially achieving the configurations of FIG. 4C and FIG. 4D,simultaneously and/or in series, the relative movement causing increasedcloseness between the applicator tool 80 and the tray 122 can continue,and the handles 94 can be manually squeezed together (e.g., pushedtoward one another) so that the applicator tool reconfigures toward itsactuated or deformed configuration and applies deforming forces on thetissue bridge 20. As the applicator tool 80 is, for example,simultaneously pushed with greater force against the tissue bridge 20and caused to deform farther toward its deformed configuration, theapplicator tool applies forces against the tissue bridge 20 so that thetissue bridge is responsively deformed toward its strained, deformed, orextended configuration. For example, the applicator tool 80 cansimultaneously apply a downward force via the contact surface 82 andlaterally outward forces via the catch parts 84.

In the transition from the configuration of FIG. 4C to the configurationof FIG. 4D, the outer portions of the foot pads 24 have moved, or morespecifically pivoted, away from the tray outer sections 132. Asdiscussed above, the flaps 138 can be attached to the outer portions ofthe foot pads 24 by way of the outer adhesive layer 42 (FIG. 1E).Therefore, the flaps 138 can be carried by, and pivot with, the outerportions of the foot pads 24. Therefore, the flaps 138 pivot outwardlyrelative to a reminder of the release liner 62 that remains fixedlymounted to the tray base panel 124. That is, the flaps 138 can pivotoutwardly relative to (e.g., at least partially delaminate from) areminder of the release liner 62 and the tray 122 in response torespective movement, reconfiguring, and/or the like of the tissue bridge20 and applicator tool 80. In the first embodiment, the release liner 62is a support that supports the tissue bridge, and each flap 138 can bereferred to as a first section of the support, and the reminder of therelease liner 62 and/or the tray 122 can be referred to as a secondsection of the support, or the like.

As another example, in the transition from the configuration of FIG. 4Cto the configuration of FIG. 4D, the protrusions 92 have pushed (e.g.,deflected) the medial struts 48 downwardly toward the recessed centralsection 130 of the tray 122 to close one or more gaps 140 (FIGS. 4A and4B) positioned between the medial struts and the tray central section.However, such strut deflection and/or closure of the gaps 140 can beoptional and may not occur. As other examples, the gaps 140 may be atleast partially closed, only partially closed and/or it is believed thatit may be possible in some situations to omit the gaps 140. That is, inan example, the medial struts 48 can pivot downwardly relative to areminder of the foot pads 24 in response to respective movement,reconfiguring, and/or the like of the tissue bridge 20 and applicatortool 80.

Referring to FIG. 4C-4F, the applicator tool 80 and tissue bridge 20 canbe cooperatively configured and engaged to one another in apredetermined manner so that, in response to the handles 94 beingmanually squeezed or pushed closer to one another, at least lowerportions of the tool catch parts 84 are moved farther away from oneanother and the contact surface 82 moves toward a line between the catchparts 84, and this movement of the applicator tool 80 forces the tissuebridge 20 into its fully deformed or extended configuration, an exampleof which is shown in FIG. 4F. For example, the manual inward forceapplied to the opposite sides of the handles 94 to achieve thisconfiguration can be in a range of from more than 0.2 pounds force (0.89newtons) to less than 2 pounds force (8.9 newtons).

In the transition from the configuration of FIG. 4E to the configurationof FIG. 4F, the release liner 62 typically fully separates from thetissue bridge 20, and the flaps 138 can pivot/fall back into theiroriginal positions in response to relative movement causing increaseddistance between the applicator tool 80 and the tray 122. The releaseliner 62 typically fully separates from the tissue bridge 20 in a mannerthat fully exposes the outer adhesive layer 42 (FIG. 1E) (e.g., patientcontact adhesive), so that there are no remnants of the release linerstuck to the tissue bridge and the outer adhesive layer is ready forbeing used to secure the tissue bridge to tissue, such as the skin of apatient.

For example, in FIG. 4F the tissue bridge 20 and applicator tool 80 areengaged to one another, and both the tissue bridge and the applicatortool are in their deformed configurations so that the tissue bridge issecurely grasped or otherwise held by the applicator tool, so that asthe applicator tool is manually moved away from the tray 122 theapplicator tool carries the tissue bridge away from the tray. While thetissue bridge 20 is securely held by the applicator tool 80, theapplicator tool can be used to apply the tissue bridge to tissue, suchas the skin of a patient.

Referring to FIGS. 4G-4K, a method of using the applicator tool 80 toapply a tissue bridge 20 to tissue 152 on either side of a cut 150 in apatient's skin 152 is described in the following, in accordance with thefirst embodiment. FIG. 4G schematically depicts with dashed lines 154the originally spaced apart edges of the cut 150, and a solid line 156schematically depicts that the edges of the cut may be manually pushedtogether prior to applying the tissue bridge 20 over the cut. Theapplicator tool 80 holding the tissue bridge 20 can be moved toward thecut 150 so that the tissue bridge 20 extends crosswise to, or morespecifically substantially perpendicular to, the length of the cut 150,and the first contact between the tissue bridge and the tissue or skin152 occurs at the inner end sections or portions of the medial struts 48on either side of the cut. Referring to FIGS. 4H and 41, the applicatortool 80 can continue to be pushed closer to the cut 150 so that theinner portions of medial struts 48 begin to become adhered to the skin152 by the outer adhesive layer 42 (FIG. 1E) (e.g., patient contactadhesive). For example, the transmission of force from the applicatortool 80, by way of the catch parts 84, against the medial struts 48 cancause the pressure-sensitive adhesive layer 42 to be engaged against thetissue 152 with sufficient force to cause the inner portions of medialstruts 48 to become adhered to the tissue 152 at opposite sides of thecut 150. Then, the manual force on the handles 94 of the applicator tool80 can be reduced, so that the tissue bridge 20 returns toward its atrest configuration, and the medial struts 48 become closer together andpush the portions of the tissue 152 to which they are adhered toward oneanother. Then, in response to the tissue bridge 20 returning farthertoward its at rest configuration, the reconfiguring of the tissue bridgecauses the outer portions of the foot pads 24 to move or pivotdownwardly into contact with the tissue 152 at opposite sides of the cut150. In one example, this contact between the outer portions of the footpads 24 and the tissue 152 at opposite sides of the cut 150 may occurwith sufficient force to cause the pressure-sensitive adhesive layer 42to securely adhere the outer portions of the foot pads 24 to the tissue152 at opposite sides of the cut 150.

In accordance with the first embodiment, the inner portions of themedial struts 48 are adhesively mounting to the tissue 152 while thetissue bridge 20 is in its deformed or extended configuration; andthereafter as the tissue bridge 20 returns toward its at restconfiguration and reaches an intermediate configuration that is betweenthe extended and at rest configurations, the remainder or outer portionsof the foot pads 24 are adhesively mounted to the tissue. When thetissue bridge 20 is first engaged against the tissue 152, the point offirst contact and adhesive mounting to the tissue can be at the innerend sections or portions of the medial struts 48, and this mounting canoccur while the medial struts are being pushed downwardly by way of theapplicator tool 80. In the first embodiment, as the deforming forcebeing applied on the tissue bridge 20 by the applicator tool 80 isreduced, the medial struts 48 move or rotate inwards, thus centrallypulling the tissues 152 to which they are adhesively mounted, and thisaction by the medial struts 48 occurs before the outer portions of thefoot pads 24 are adhesively attached to the tissue. At this intermediatepoint, in which the medial struts 48 are at least partially attached tothe tissue 152 and have moved inwards, and the outer portions of thefoot pads 24 are not yet attached to the tissue, the shear stress and/orstrain on predetermined tissue (i.e., tissue that is lateral to thelateral-most contact point between the medial strut and the tissue) isdistributed laterally and in a gradual manner. Then, when the lateral orouter portions of the foot pads 24 are pressed down and adhered to thetissue 152, the predetermined tissue underneath and at the lateral edgesor outer edges of the foot pads 24 is secured (e.g., adhered to the footpads) in its state in which the stress and/or strain in thepredetermined tissue is distributed laterally and in a gradual manner,which seeks to prevent sudden, high sheer stress at the lateral edges(e.g., opposite ends) of the tissue bridge 20.

Referring to FIG. 4K, the applicator tool 80 can then be removed fromthe tissue bridge 20 so that the tissue bridge remains mounted over thecut 150; then the applicator tool may be used to install another tissuebridge. As an example, the distance between the tips of the protrusions92 can be greater than the distance between the hole edges 58 (FIGS. 1Aand 1B). In such an example, upper surfaces or engagement shoulders 93of the catch parts 84 can extend obliquely downwardly from the shanks90, so that there can be relative sliding between the shoulders 93 andthe edges 83 when the applicator tool 80 is withdrawn from the tissuebridge. In response to such sliding, the catch parts 84 can pivot towardone another and, thus, be freed from the holes 56. Alternatively, thecatch parts 84 can be moved toward one another in any other suitablemanner as part of the catch parts 84 being freed from the holes 56. Asanother example, after a tissue bridge 20 is mounted to a patient andthe applicator tool 80 is allowed to return to its relaxedconfiguration, the tissue bridge 20 may reconfigure toward its relaxedconfiguration without fully reaching its relaxed configuration, so thatthe protrusions 92 can freely pass through the holes 56.

A user can push down manually with their fingers 157 on the foot pads24, for example with sufficient force to ensure that thepressure-sensitive adhesive layer 42 securely adheres the foot pads 24to the tissue 152 at opposite sides of the cut 150. In accordance withthe first embodiment, the tissue bridge 20 can be mounted to the tissue152 in a manner such that the tissue bridge and tissue apply forceagainst one another, and the force applied by the tissue typicallyrestricts the tissue bridge from fully returning to its at restconfiguration. As a result, the tissue bridge 20 applies compressiveforce to the tissue 152 by way of the foot pads 24, as schematicallydepicted in FIG. 4K by arrows 158, in a manner that can, for example,reduce tension in the tissue, help close the wound 150, help inhibitwound reopening and/or inhibit scar disfiguring (e.g., widening). In theexample shown in FIG. 4K, the tissue 152 proximate the scar and/or wound150 bulges into the central area over which the arch 28 extends.

In association with the forces being applied against one another by thetissue 152 and the tissue bridge 20 when the tissue bridge is mounted,for example, as shown in FIG. 4K, the medial struts 48 are typicallyunder longitudinal compression. In addition, the medial struts 48 can beconfigured in a manner that seeks to allow the arch 28 and medial strutsto move in a manner that provides a wide opening 160 (FIG. 4G) for atleast partially enveloping the subject tissue 152, wound 150, scar, orthe like, so that the tissue bridge 20 can function to substantiallyinhibit any tension in the tissue, wound reopening, and/or scardisfiguring (e.g., widening). In addition, the medial struts 48 canadvantageously reach inwardly toward the margins of the wound (or scar).In addition, the medial struts 48 can flex upwards or downwardsindependently to compensate for changes in tissue tension (e.g. due toswelling) or for off-centered placement of the tissue bridge; therefore,the medial struts may help align the margins of the wound (or scar) tothe same vertical height.

In alternative embodiments, the applicator tool 80 may be replaced withone or more other suitable tools or features configured for providingone or more forces corresponding to the downward force provided via thecontact surface 82 and the laterally outward forces provided via thecatch parts 84. Such alternative tools may comprise a plunger mechanism,a side-directed pliers mechanism, a cam-activated mechanism, and/or anyother suitable features, and such alternative tools may be multi-piecetools. As another example, the tissue bridges 20 may be applied totissue 152 using one or more straps, or the like, as will be discussedin greater detail below.

Numerous other embodiments are within the scope of this disclosure. Forexample, other embodiments (e.g., embodiments two through fourteen) ofthis disclosure can be configured and/or function at least generallylike the first embodiment, except for variations noted and variationsthat will be reasonably apparent to those of ordinary skill in the art.Accordingly, some of the drawing reference numerals used in theforegoing are used in the following and/or reference numerals forsimilarly configured and/or similarly functioning features may beincremented by two hundred, or other amounts, in the following.

Referring to FIGS. 5A-5D regarding a tissue bridge 320 of a secondembodiment, the outer extension(s) 350 of the outer sheets 334 extendfarther outwardly as compared to the corresponding features of the firstembodiment. In addition, the inner sheets 336 include outer extensions350′ that extend outwardly past the outer edges of the respective footplate or flange 326, and are recessed inwardly relative to the outeredge of the respective outer extension 350. The holes 356 can beincluded in the bodies 322, or these holes can be omitted, since thetissue bridge 320 may be mounted using features other than theapplicator tool 80 of the first embodiment.

As shown in FIGS. 5A-5D, by way of the outer adhesive layer 42 (FIG. 1E)(e.g., patient contact adhesive), at least one central release or peelliner 462 and one or more release or peel liner mounting straps 464 arerespectively mounted to the foot pads 324. Inner ends of the mountingstraps 464 can include at least one folded over flap 465. The centralrelease liner 462 can define or include at least one tab 466, and thetab can extend from the side of the central release liner. In the secondembodiment, the mounting straps 464 are longer than the central releaseliner 462 and configured so that they can be used as an applicator toolfor mounting the tissue bridge 320 to tissue 452. Each of the releaseliners 462, 464 can be, for example, a release liner in the form of apaper or plastic-based film sheet coated with a release agent that isengaged against the outer adhesive layers 42 so that the tissue bridge320 is releasably mounted on the release liners 462, 464.

Referring to FIGS. 6A-6F, a method applying the tissue bridge 320 ontotissue 452 including a wound 450 is described in the following, inaccordance with the second embodiment. Referring to FIG. 6A and thenFIGS. 6B-6D, the tab 466 (FIGS. 5A-5C) can be manually grasped andpulled to remove the central release liner 462 and expose the outeradhesive layer 42 on at least the medial struts 348. Then, the free endsof the release liner mounting straps 464 may be drawn together andpulled, such as by fingers 457, while another finger 457 pushesdownwardly on the arch 328 so that deforming forces are applied on thetissue bridge 320, and the inner portions of the medial struts 348 beginto become adhered to the tissue 452 by the outer adhesive layer 42 (FIG.1E) (e.g., patient contact adhesive). In the second embodiment, themounting of the tissue bridge 320 onto the tissue 452 can be carried outat least generally similarly to the first embodiment, so that after themedial struts 348 are at least partially attached to the tissue 452 andhave moved inwards, and the outer portions of the foot pads 324 are notyet attached to the tissue, the shear stress and/or strain onpredetermined tissue (i.e., tissue that is lateral to the lateral-mostcontact point between the medial strut and the tissue) is distributedlaterally and in a gradual manner; and then, when the lateral or outerportions of the foot pads 324 are pressed down and adhered to the tissue452, the predetermined tissue underneath and at the lateral edges orouter edges of the foot pads 324 is secured (e.g., adhered to the footpads) in its state in which the stress and/or strain in thepredetermined tissue is distributed laterally and in a gradual manner,which seeks to prevent sudden, high sheer stress at the lateral edges(e.g., opposite ends) of the tissue bridge 320.

Referring to FIGS. 6E and 6F, the mounting straps 464 can be removedfrom the tissue bridge 320 by manually grasping and pulling the flaps465. Then, a user can push down manually on the foot pads 324 withsufficient force to ensure that the pressure-sensitive adhesive layer 42securely adheres the foot pads to the tissue 452 at opposite sides ofthe scar or wound 150.

Referring to FIG. 7, in a third embodiment, the outer ends of themounting straps 464 can be fixedly connected to one another by way ofany suitable mechanical fasteners 459, adhesive material 459, or thelike, so that a user may apply the tissue bridge using the fingers 457of a single hand. Referring to FIGS. 6C and 7, joining the outer ends ofthe mounting straps 464 together, for example manually and/or with oneor more fasteners 459 and/or adhesive material 459, can cause not onlythe arch 328 to flex, but also the shoulders 432 and foot plates orflanges 426 to flex when the tissue bridge 320 is in its deformed orextended configuration.

FIG. 8A depicts an applicator tool 580; FIG. 8B depicts the applicatortool 580 in receipt of a tissue bridge 520; and FIG. 8C depicts that thetissue bridge 520 and applicator tool 580 are engaged to one another,and both the tissue bridge and the applicator tool are in their deformedconfigurations so that the tissue bridge is securely grasped orotherwise held by the applicator tool, in accordance with a fourthembodiment. Referring to FIG. 8A, the contact surface 582 can be a lowerend face of a central link 586A, and outer links 586B can extendobliquely upward from the central link 586A to levers 588 or handles594. The catch parts 584 can include shanks 590 extending downwardlyfrom lower ends of the levers 588 or handles 594. Each catch part 584can further include at least one protrusion 592 extending outwardly fromthe lower end of the shank 590 in a direction that can be crosswise tothe length of the shank. The protrusions 592 can extend along, or morespecifically parallel to, the length of the contact surface 582.Referring to FIGS. 8B and 8C, the protrusions 592 can enter thereceptacles 552 (which are partially defined by the medial struts 548)through side openings of the receptacles 552.

FIG. 9A depicts an applicator tool 780; FIG. 9B depicts the applicatortool 780 in receipt of a tissue bridge 720; and FIGS. 9C and 9D depictthat the tissue bridge 720 and applicator tool 780 are engaged to oneanother, and both the tissue bridge and the applicator tool are in theirdeformed configurations so that the tissue bridge is securely grasped orotherwise held by the applicator tool, in accordance with a fifthembodiment. Referring to FIG. 9A, the contact surface 782 can be a lowerend face of a central link 786A, and outer links 786B can extendobliquely upward from the central link 786A to levers 788 or handles 794joined to one another at their upper ends. The catch parts 784 caninclude shanks 790 extending downwardly from lower ends of the levers788 or handles 794. Each catch part 784 can further include at least oneprotrusion 792 extending outwardly from the lower end of the shank 790in a direction that can be crosswise to the length of the shank. Theprotrusions 792 can extend along, or more specifically parallel to, thelength of the contact surface 782. Referring to FIGS. 9B-9D, theprotrusions 792 can enter the receptacles 752 (which are partiallydefined by the medial struts 748) through side openings of thereceptacles 752.

FIG. 10A depicts a tissue bridge 920, in accordance with a sixthembodiment. The catch holes 956, which extend through the body 922 andare open to the receptacles 952, can also be open at the side edges ofthe body. FIGS. 10B and 10C depict an applicator tool 980 in receipt ofthe tissue bridge 920; and FIGS. 10D and 10E depict that the engagedtogether tissue bridge 920 and applicator tool 980 are both in theirdeformed configurations so that the tissue bridge is securely grasped orotherwise held by the applicator tool, in accordance with the sixthembodiment. The catch part shanks 990 can enter respective catch holes956 from the side, and the catch part protrusions 992 can enter thereceptacles 952 (which are partially defined by the medial struts 948)through side openings of the receptacles 952.

FIG. 11A depicts a tissue bridge 1120 of a seventh embodiment. In theseventh embodiment, the catch holes 1156 are in the form of a slot 1156that extends through the body 1122 and is open to the receptacles 1152.FIGS. 11B and 11C depict an applicator tool 1180 in receipt of thetissue bridge 1120; and FIGS. 11D and 11E depict that the engagedtogether tissue bridge 1120 and applicator tool 1180 are both in theirdeformed configurations so that the tissue bridge is securely grasped orotherwise held by the applicator tool, in accordance with the seventhembodiment. The catch parts 1184 extend downwardly through the slot1156. An enlarged section of the lower end of the applicator tool'scentral link 1186A fits into the slot 1156, and protrusions 1187extending from opposite sides of the lower end of the central link 1186Aengage against the upper surfaces of the arch 1128 at opposite sides ofthe slot 1156. The levers 1188 or handles 1194 can be joined to oneanother at their upper ends, and tabs 1168 or other suitable structuresextending inwardly from the levers 1188 or handles 1194 can engage oneanother to restrict any further inward movement of the levers 1188 orhandles 1194 when the engaged together tissue bridge 1120 and applicatortool 1180 are both in their deformed configurations. For example, thetabs 1168 and or other suitable features can be configured to come intocontact with one another when the desired degree of deformation isreached in the tissue bridge 1120, thereby seeking to prevent overdistortion of the tissue bridge.

As at least alluded to above, the tissue bridges and applicator tools ofthe third through seventh embodiments can be cooperatively configuredwith respect to one another at least generally like the tissue bridgesand applicator tools of first embodiment. For example and referring backto FIGS. 4C and 4D, the tissue bridges and applicator tools of the thirdthrough seventh embodiments can be cooperatively configured to functionlike tissue bridges and applicator tools of the first embodiment withregard to the catches or protrusions 92 engaging and pushing (e.g.,deflecting) the medial struts 48 downwardly.

FIGS. 12A and 12B depict an applicator tool 1380 in receipt of a tissuebridge body 1320; and FIGS. 12C and 12D depict that the engaged togetherapplicator tool 1380 and tissue bridge body 1320 are both in theirdeformed configurations so that the tissue bridge body is securelygrasped or otherwise held by the applicator tool, in accordance with aneighth embodiment. The catch parts 1384 can comprise receptacles, ormore specifically slots, into which opposite ends of the tissue bridgebody 1320 respectively extend. The levers 1388 or handles 1394 can haveloops, partial loops, handles and/or other suitable features fixedlyconnected at their upper ends or therealong for receiving fingers of anoperator of the tool 1380, and another finger can be pressed downwardlyon a platform and/or other suitable features at the upper end of thecentral link 1186A.

The applicator tool 1380 can have a first body comprising a first lever1388 connected to a first catch part 1384, and a second body comprisinga second lever 1388 connected to a second catch part 1384. Referring toFIGS. 12B and 12C, the reconfigurable linkage (e.g., linkages 1186A,1186B) can connect the first and second bodies to one another, and beconfigured so that (e.g., simultaneously): the first and second bodiesare pivotable relative to one another about first and second axes 1371,1372, respectively; and the first and second axes 1371, 1372 are movabletoward and away from one another. The levers 1388, handles 1394, linkage(e.g., linkages 1186A, 1186B) and/or other suitably associated featurescan have a variety of different configurations to assist inergonomically optimized use, for example by comprising partial orcomplete rings, recesses shaped to accept the user's digit(s) and/orother suitable features.

FIGS. 13A and 13B depict a tissue bridge 1520 of a ninth embodiment. Asshown in FIG. 13A-13C, the catch holes 1556 can extend through the footplates or flanges 1526. Referring to the exploded view of FIG. 13C, thetissue bridge 1520 includes inner and intermediate adhesive layers 1538,1540 respectively between and fixedly connecting the inner sheets 1536to the flanges 1526, and the outer sheets 1534 to the inner sheets. Thetissue bridge 1520 can further include lower holes 1527 in the inneradhesive layers 1538 and inner sheets 1536. The lower holes 1527 can beopen to the catch holes 1556, and the lower holes 1527 can also extendoutwardly to be open at the outer edges of the inner adhesive layers1538 and inner sheets 1536. As discussed in greater detail below, thecatch holes 1556 can mate with respective portions of applicator tools.In addition and/or alternatively, the holes 1527, 1556 (e.g., openwidows) can provide pathways for ventilation/moisture transmission.

FIG. 13D depicts the tissue bridge 1520 mounted in a tray 1622, andFIGS. 13E and 13F depict some of the steps of a method of using theapplicator tool 1580 to remove the tissue bridge from the tray 1622, inaccordance with the ninth embodiment. For example, in response torelative movement causing increased closeness between the applicatortool 1580 and the tray 1622, or more specifically movement of theapplicator tool toward the tissue bridge 1520 mounted in the tray, thetool catch parts 1584 can enter the inner lower holes 1527 by way of theouter holes 1556, so that respective portions of the outer sheets 1534can be engaged by, and pushed (e.g., stretched) outwardly by, theprotrusions 1592; and the catch parts 84 become releasably connected tothe tissue bridge 1520. The inner lower holes 1527 can further extendthrough other layers of the foot pads 1524. In the ninth embodiment,when the applicator tool 1580 is operated to cause the both theapplicator tool and the tissue bridge 1520 to be in their deformedconfigurations so that the tissue bridge is securely grasped orotherwise held by the applicator tool, not only the arch 1528 flexes,but also the shoulders 1532 and foot plates or flanges 1526 flex,similarly to as shown in FIGS. 6C and 7.

FIG. 14 is a bottom pictorial view of an applicator tool 1780, inaccordance with a tenth embodiment. In the tenth embodiment, the bearingor contact surface 1782, which is positioned between the catch parts1784 for pressing against the apex of the arch of a tissue bridge, isdefined at the juncture between links 1786 and/or at the lower point ofat least one link 1786. The one or more links 1786 can extend obliquelyupward from the contact surface 1782 to the levers 1788 or handle 1794.FIG. 15 is a top plan view of a tray 1822 at least partially containingthe applicator tool 1780 and a series of tissue bridges 1720.

Other embodiments are also within the scope of this disclosure. Forexample, catch parts of the tissue bridges can include hook-shapedmembers, shelves, shoulders or other catch-like features extendingupwardly from the foot plates or flanges for engaging with catches ofthe applicator tools. In another example, the shoulders and foot platesor flanges may be omitted from the body of a tissue bridge, and curvedfoot pads, which can comprise curved medial struts, can be connectedeither directly or indirectly to the arch of such a tissue bridge.

As another example, one or more therapeutic agents can optionally beincluded in any of the above-described kits, packages, and/or in or onthe tissue bridges. For example, a medicinal, a biologic (e.g. amnion orchorion), growth factors, wound healing factors, drugs (woundmodulators, steroids, antibiotics), and/or other suitable therapeuticagents can be included in the kits, packages, and/or in or on the tissuebridges in a manner that seeks to improve wound healing, reduce scars,and/or reduce complications. As one specific example, an element ormedium that is in addition to or an additional part of a tissue bridgemay comprise the therapeutic agent, and such a medium may be associatedwith any of the above-descried tissue bridges.

FIGS. 16A-16C depict some of the steps of a method of associating amedium with one or more of the tissue bridges 20 of the firstembodiment, although the method may be carried out with any othersuitable tissue bridges, or the like. The medium can be in the form of astrip 170 of material such as, but not limited to, silicone tape. FIG.16A depicts an elongate scar or wound 150 in tissue 152, for example theouter surface of a patient's epidermis. Referring also to FIG. 16B, thescar or wound 150 can be covered with the strip 170, wherein thecovering strip typically extends along the scar or wound. Referring toFIGS. 16C and 16D, one or more of the tissue bridges 20 can be mountedto the tissue 152 so that the tissue bridges extend across the strip170, and for each tissue bridge the strip extends between the inneredges of the foot pads 24, or more specifically the strip extendsbetween the inner edges of the medial struts 48.

In the example shown in FIG. 16D, the strip 170 is not fixedly connectedto the tissue bridges 20, but can optionally be connected to the tissue152 with releasable adhesive material 172. Alternatively, in the exampleshown in FIG. 16E, the strip 170 can be fixedly connected to the arch 28with adhesive material 174. Referring to FIG. 16E, the relative sizes offeatures can be such that strip 170 can be engaged to both the undersideof the arch 28 and the scar or wound 150, for example in a manner thatseeks to holed the strip in place, whether or not the adhesive material174 is present. For example, the strip or medium 170 can be a foam ofsuch a thickness that the one or more tissue bridges 20 slightly pushdown on the foam to maintain good contact between the foam and scar orwound 150, wherein the foam is or can optionally include one or moretherapeutic agents, such as silicone.

In addition or alternatively, the strip can be mounted to the arch 28.For example, regarding a method related to FIG. 16E, the underside ofone or more of the arches 28 can be fixedly connected to the strip 170by adhesive material 174 during original manufacture of the one or moretissue bridge, so that the strip 170 is originally engaged against thescar or wound 150 in the tissue 152 at the same time that the one ormore tissue bridges are mounted to the tissue. That is, multiple tissuebridges 20 may be fixedly mounted to a single strip 170 and/or eachtissue bridge may be mounted to a separate strip. For the latterexample, for each tissue bridge 20, the strip 170 can be wider than thewidth of the tissue bridge, so that end sections of adjacent the stripsabut and/or overlap one another when a series of the tissue bridges areapplied adjacent to one another.

Referring to FIG. 16F, in addition to the strip or medium 170 beingpositioned between the inner edges of the foot pads 24 or medial struts48, the strip or medium can also extend at least partially over themedial struts, such as, for example, to accommodate a relatively largerarea of the adhesive material 174. In one aspect of this disclosure, thestrip or medium 170 may or may not extend lateral to the level of themedial edges of the medial struts 48 in the at rest configuration of thetissue bridge 20. For example, FIG. 16G depicts a side view of a tissuebridge 20 in its at rest configuration, wherein the strip or medium 170is fixedly connected to the underside of the arch by the adhesivematerial 174, and the strip or medium 170 is configured to be positionedat least partially between the foot pads 24 and/or medial struts 48 whenthe tissue bridge is mounted to tissue 152, for example as shown in oneor more of FIGS. 16D-F.

Reiterating from above, in one example the strip 170 can comprisesilicone, or be a silicone strip. As other examples, the strip 170 canbe any suitable medium comprising one or more therapeutic agents,examples of which are mentioned above. As additional examples, thestrips or mediums 170 can comprise or otherwise embrace other materialsand various geometries/forms of materials such as, but limited to,foams, fabrics (wovens, non-wovens, and/or felts) laminations ofsame/differing materials, and the like, that can carry and/or compriseone or more therapeutic agents. The materials can have one or moreproperties that work with or enable the therapeutic agents. As anotherexample, the strips or mediums 170 can comprise biodegradable materialssuch as, but not limited to, polymers that can be “doped” withtherapeutic agents so that as the polymers break down the therapeuticagents are released. Alternatively, the strip or medium 170 may notcontain or otherwise carry any therapeutic agent, and can be, or canfunction as, a dressing, tape or other suitable medical covering forengaging the scar or wound 150. As another example, one or moretherapeutic agents can be applied to the scar or wound 150 in aconventional manner, and thereafter the strip or medium 170 and tissuebridge 20 may be mounted over the one or more therapeutic agents on thescar or wound.

An eleventh embodiment of this disclosure is the same as the first andninth embodiments discussed above, except for variations noted, andvariations that will be apparent to those of ordinary skill in the art.Accordingly and for example, like drawing reference numerals are usedfor the first and eleventh embodiments, except that the referencenumerals for the eleventh embodiment are typically incremented by twothousand as compared to the first embodiment.

FIGS. 17A-17E depict the at least partially elastic (e.g., generallyelastic) medical article 2020 in its undeformed or at restconfiguration, in accordance with the eleventh embodiment. At leastpartially reiterating from above, the medical article 2020 mayoptionally be referred to as a force modulating tissue bridge 2020, orsimply tissue bridge 2020, and throughout this disclosure the tissuebridge may be more generally referred to as a medical article.

Referring primarily to FIG. 17A, the tissue bridge 2020 of the eleventhembodiment comprises a generally elastic body 2022 and one or moremulti-layer foot pads 2024 mounted to the body, although in someexamples one or more of the foot pads and/or portions thereof can beomitted (e.g., a foot-pad may consist of, or consist essentially of, asingle layer). The body 2022 can be generally referred to as and/orgenerally function as a backbone or other suitable structure configuredto movably connect two or more of the foot pads 2024 to one another. Thebody 2022 can include at least two flanges 2026 (e.g., feet)respectively extending obliquely, for example outwardly and downwardly,from opposite lower portions of a central section or arch 2028 of thebody. Each of the flanges 2026 can be planar, or they can besubstantially or about planar since it may not be critical that theflanges be exactly planar. The flanges 2026 can extend divergentlyrelative to one another, and obliquely relative to one another. The arch2028 can include a central spanning section 2030, and lower sections2032 respectively extending downwardly from opposite portions of thespanning section. The lower sections 2032 of the arch 2028 canoptionally be configured as and/or referred to as shoulders 2032. Theflanges 2026 can respectively extend obliquely, for example outwardlyand downwardly, from lower portions of the shoulders 2032. The shoulders2032 can provide a smoothly curved transition between the spanningsection 2030 of the arch 2028 and the flanges 2026.

In one example, the arch's central spanning section 2030 can be thickerthan the flanges 2026, and other variations are within the scope of thisdisclosure. For example, whereas the arch 2028 is typically depicted inthe drawings as being at least generally arcuate, it is believed that insome situations the arch 2028 can be at least more of a flat arch, orthe spanning section 2030 of the arch can be flat, or the arch orfeatures thereof can be in any other suitable configurations that willallow the tissue bridge 2020 to function generally or substantially asdescribed herein.

Each of the parts of the tissue bridge 2020 will typically beconstructed of suitable medical-grade materials. For example, the body2022 can be an injection-molded or mechanically thermoformed, unitary(e.g., single-piece) article such that the spanning section 2030,shoulders 2032 and flanges 2026 can be formed together as a singlearticle from an injection-moldable or formable, generally elasticmaterial such as, but not limited to, polycarbonate, or any othersuitable injection-moldable or formable material. Each of the spanningsection 2030, shoulders 2032, and flanges 2026 can be about the samethickness, or alternatively the thickness of the body 2022 can varyalong its length. The width of the body 2022 can, for example, taperalong its length, so that the spanning section 2030 is relatively narrow(e.g., has a narrowed waist) as compared to the shoulder 2032 andflanges 2026, so that the spanning section can be more readily deformedas compared to the shoulders and flanges. For example, the side edges ofthe spanning section 2030 can be inwardly curved or concave, or they mayhave a stepped or other suitable configurations. Alternatively, the sideedges of the spanning section 2030 can extend generally or substantiallystraight in a top plan view of the tissue bridge 2020, or they canextend in any other suitable manner.

The foot pads 2024 can be spaced apart from one another, and the footpads can be fixedly mounted to the flanges 2026. Each foot pad 2024 canbe or include be a mat, laminate or other suitable structure comprisingone or more layers of material. For example, each foot pad 2024 caninclude an outer layer or sheet 2034 configured to be attached to tissue(e.g., skin tissue), and an inner layer or sheet 2036 positionedbetween, and fixedly connected to each of, the outer sheet 2034 and therespective flange 2026.

Referring to the exploded view of FIG. 17F, the tissue bridge 2020 caninclude inner, intermediate and outer adhesive layers 2038, 2040, 2042.The inner adhesive layers 2038 can be between and fixedly connect theinner sheets 2036 to the flanges 2026, the intermediate adhesive layers2040 can be between and fixedly connect the outer sheets 2034 to theinner sheets, and the outer adhesive layers 2042 can be on the outersides of the outer sheets for attaching the tissue bridge 2020 to tissue(e.g., a patient's skin).

The outer and inner sheets 2034, 2036 can be provided by die cuttingthem from appropriate webs or larger sheets of material, such as fabricor cast microporous polymeric sheet for the outer sheets 2034, and anextruded polymer or plastic sheet for the inner sheets 2036. The outersheets 2034 can be made of suitable fabric materials, cast materials,films, or other materials of the type from which skin-contact layers ofbandages or other wound dressings are formed, or any other suitablematerial. The plastic inner sheets 2036 can be made of suitablematerials such as, for example, polyethylene, polyethyleneterephthalate, or any other suitable materials. The outer adhesive layer2042 can have a lower adhesive strength than the inner and intermediateadhesive layers 2038, 2040, such as when the tissue bridge 2020 is to beremovably mounted to tissue (e.g., a patient's skin).

Both the body 2022 and the inner sheet 2036 can have a higher modulus ofelasticity (e.g., are formed from stiffer material) than the outer sheet2034. More generally, the body 2022 and the inner sheet 2036 can bestiffer than the outer sheet 2034 because of a variety of factors, suchas being larger, thicker and/or comprising material having a highermodulus of elasticity. The body 2022, including its flanges 2026, can bethicker than each of the outer and inner sheets 2034, 2036, although thethicknesses can be varied. The arch 2028 can extend over an area intowhich portions of the outer and inner sheets can optionally extend. Thearea over which the arch 2028 extends may be referred to as a centralarea, a treatment area, an under-arch area, and/or the like.

Referring to FIG. 17C, inner extensions 2048 of the outer and innersheets 2034, 2036 can extend congruently with one another into thecentral area over which the arch 2028 extends such that the innerextensions 2048 are neither superposed by nor coextensive with theflanges 2026. More generally, each foot pad 2024 can include at leastone extension 2048 that extends into the central area over which thearch 2028 extends such that the inner extension 2048 can be neithersuperposed by nor coextensive with the flanges 2026. The innerextensions 2048 may be referred to as medial extensions 2048, forexample since they extend toward the middle of the area over which thearch 2028 extends. The inner or medial extensions 2048 can be configuredso that they at least partially resist longitudinal compression when thetissue bridge 2020 in its extended configuration is mounted to tissue(e.g., skin tissue) and then allowed to generally elasticallyreconfigure from its extended configuration at least partially towardits at rest configuration. Accordingly, the inner or medial extensions2048 can be referred to as medial struts 2048. A gap can be definedbetween adjacent ends of the medial extensions 2048, and the gap can beconfigured, for example, so that the adjacent ends of the medialextensions 2048 are spaced apart from one another and do not contact oneanother.

Referring to FIG. 17B, for each foot pad 2024, one or more (e.g., four)margins or outer extensions of the outer sheets 2034 can extendoutwardly beyond the inner sheet 2036 such that they are neithersuperposed by nor coextensive with the inner sheet 2036. In the eleventhembodiment, each medial strut 2048 includes the inner extensions 2048 ofboth sheets 2034, 2036, but one or more layers or sheets of the medialstrut 2048 can be omitted, such that each medial strut can be formed ofone or more layers of material.

Referring to FIG. 17C, the medial struts 2048 can be spaced apart from(e.g., at least partially spaced apart from) the arch 2028 and extendinto the central area over which the arch extends, so that gaps orreceptacles 2052 are at least partially defined between the medialstruts and the arch. The receptacles 2052 can at least partially define,or be at least part of, catch parts configured for interacting withcorresponding features of an applicator tool that may be used, forexample, in the mounting of the tissue bridge 2020 to tissue (e.g., apatient's skin). For example, the tissue bridge 2020 can include one ormore catch parts that respectively comprise the receptacles 2052. Avariety of differently configured catch parts are within the scope ofthis disclosure.

The body 2022 can include at least two catch parts that further compriseinner holes 2056 that extend through the body 2022 and are open to thereceptacles 2052. The inner holes 2056 can be defined in the arch 2028,or more specifically the inner holes 2056 can be positioned in oppositeend portions of the spanning section 2030. The inner holes 2056 can beopen to the central area over which the arch 28 extends, or morespecifically the inner holes can be open to the receptacles 2052; andthe medial struts 2048 can extend beneath the inner holes. The innerholes 2056 can have any suitable shape. For example, they can begenerally polygonal, or generally rectangular, with an edge 2058 of thearch 2028 that defines the inner hole 2056 extending crosswise to thelength of the arch.

The respective catch part can further include the edge 2058 and aprotrusion or rib 2057 extending downwardly from (e.g., downwardly fromproximate) the edge 2058. The edge 2058 and rib 2057 can extendparallel, or more generally substantially parallel or about parallel, tothe boundary between the spanning section 2030 and the respectiveshoulder 2032. In other words, the edge 2058 and rib 2057 can extendperpendicular to, or more generally substantially perpendicular to orabout perpendicular to, the lengthwise or longitudinal axis of the body2022. In addition, the inner holes 2056, when present, can reduce thearea or volume of the outer portions of the spanning section 2030 in amanner that enhances the deformability of the outer portions of thespanning section. At least partially reiterating from above, each catchpart can include a protruding portion 2057 of the lower surface of thearch 2028, wherein the protruding portion or rib 2060 extends outwardlyfrom, or adjacent to, the edge 2058.

The inner holes 2056 can be omitted and/or the body 2022 can have one ormore other holes formed therein or therethrough. For example, outerholes 2059 can extend through the foot plates or flanges 2026. Referringto the exploded view of FIG. 17F, the adhesive layers 2038, 2040 andinner sheets 2036 can further include lower holes 2027. The lower holes2027 can be open to the outer holes 2059, and the lower holes 2027 canalso extend outwardly to be open at the outer edges of the adhesivelayers 2038, 2040 and inner sheets 1536. The outer holes 2059 can haveany suitable shape. For example, the outer holes 2059 can be generallypolygonal, or generally rectangular. The lower holes 2027 can be shapedcomplementary to the outer holes 2059.

FIG. 17F, in addition to depicting the tissue bridge 2020 in an explodedconfiguration, further depicts the tissue bridge 2020 exploded away froma schematically depicted section of a release liner 2062 and associatedadhesive material 2064. As an example, after a tissue bridge 2020 ismanufactured or as part of the manufacturing process for the tissuebridge, the tissue bridge, or more specifically the outer sheets 2034 byway of the outer adhesive layers 2042, can be releasably mounted on theupper surface of the release liner 2062. In addition, the lower surfaceof a portion of the release liner 2062 can be fixedly mounted to asupport (e.g., tray) by way of the adhesive material 2064. The releaseliner 2062 can be, for example, a paper or plastic-based film sheetcoated with a release agent that is engaged against the outer adhesivelayers 2042 so that the tissue bridge 2020 is releasably mounted on therelease liner. The release liner 2062 can include a series of lines ofdisruption 2136. Each line of disruption 2136 can comprise one or morecuts, slits, breachable lines of disruption, perforations and/oroverlapping and/or sequential combinations thereof, for at leastpartially defining flaps 2138 in the release liner 2062. The lines ofdisruption 2136 can be configured in a variety of patterns. In theeleventh embodiment, each line of disruption 2136 extends partiallyaround the foot pad 2024 that is mounted to the flap 2138 defined by theline of disruption 2136, and opposite ends of the line of disruption2136 extend beneath the food pad. The lines of disruption 2136 can beformed as part of a cutting (e.g., die cutting) step, or the like, suchthat the lines of disruption 2136 (e.g., slits, perforations or othersuitable cuts) may extend at least partially into one or more layers ofthe foot pad 2024. As a more specific example, the lines of disruption2136, or extensions thereof, or the like, may extend into the outeradhesive layer 2040 and outer sheet 2034. Similarly, perforations oradditional lines of disruption 2137 (e.g., perforations arranged inseries) can be defined in the outer sheet 2034 and/or release liner2062. The adhesive material 2064 is typically arranged in a pattern suchthat the adhesive material is omitted from between the flaps 2138 in therelease liner 2062 and the respective portions of the tray, so that theflaps can be moved relative to the reminder of the release liner. Inthis regard, the adhesive material 2064 can be applied in any suitablepattern. For example, for a representative flap 2138, the adhesivematerial 2064 can extend along at least one of the edges of the flapwithout adhering the flap to the associated tray, or the like.

For example and like the first embodiment and at least some of the otherembodiments, the tissue bridge 2020 of the eleventh embodiment can beconfigured so that each flange 2026 has opposite upper and lowersurfaces that are each larger than a thickness defined between the upperand lower surfaces of the flange; each foot pad 2024 has opposite upperand lower surfaces that are each larger than a thickness defined betweenthe upper and lower surfaces of the foot pad; and for each flange 2026and the respective foot pad 2024 connected thereto, the upper surface ofthe foot pad and the lower surface of the flange: can face toward oneanother, can be superposed with one another, can be parallel (e.g.,substantially parallel) to one another, and/or can be directly connectedto one another by the inner adhesive layers 2038 positionedtherebetween.

It is believed that the configuration (e.g., size) of the tissue bridge2020 can be adjusted so that the tissue bridge can be well suited for avariety of different situations. Notwithstanding, for promoting ease ofunderstanding, and not for the purpose of limiting the scope of thepresent invention, a few examples of dimensions and ratios are providedin this Detailed Description section of this disclosure. For example, inFIG. 17B, the lengths “L1” and widths “W1” of the upper and lowersurfaces of the flanges 2026 are designated. In FIG. 17C the thicknesses“T” defined between the upper and lower surfaces of the flanges 2026 isdesignated. The flange thicknesses T are smaller than the flange lengthsL1 and widths W1. Also in FIG. 17B, a width “W2” of the central spanningsection 2030 of the arch 2028 is designated, and it is narrower than thewidths W1 of the flanges 2026. As one example, the overall length of thetissue bridge 2020 in its relaxed state (i.e., in its at restconfiguration) can be in a range of from about 1 inch (about 25 mm) toabout 1.6 inches (about 41 mm), or more specifically about 1.3 inches(about 33 mm); the lengths L1 of the upper and lower surfaces of theflanges 2026 can be in a range of from about 0.22 inches (about 5.6 mm)to about 0.35 inches (about 8.9 mm), or more specifically about 0.28inches (about 7.1 mm); the widths W1 of the upper and lower surfaces ofthe flanges 2026 can be in a range of from about 0.3 inches (about 7.6mm) to about 0.5 inches (about 12.7 mm), or more specifically about 0.4inches (about 10.2 mm); the flange thicknesses T defined between theupper and lower surfaces of the flanges 2026 can be in a range of fromabout 0.016 inches (about 0.41 mm) to about 0.024 inches (about 0.61mm), or more specifically about 0.02 inches (about 0.51 mm); and thewidth W2 of the arch central spanning section 2030 can be in a range offrom about 0.2 inches (about 5.1 mm) to about 0.3 inches (about 7.6 mm),or more specifically about 0.25 inches (about 6.3 mm). Accordingly, theupper and lower surfaces of the flanges 2026 (e.g., the flange lengthsL1 and/or widths W1) can be at least two, several or many times largerthan the thickness T defined between the upper and lower surfaces of theflange. Other dimensions and/or ratios are within the scope of thisdisclosure.

In other examples, the overall length of the tissue bridge 2020 in itsrelaxed state (i.e., in its at rest configuration) can be in a range offrom about 0.65 inch (about 16 mm) to about 3.5 inches (about 88 mm), ormore specifically about 1.3 inches (about 33 mm); the lengths L1 of theupper and lower surfaces of the flanges 2026 can be in a range of fromabout 0.14 inches (about 3.6 mm) to about 0.66 inches (about 16.7 mm),or more specifically about 0.28 inches (about 7.1 mm); the widths W1 ofthe upper and lower surfaces of the flanges 2026 can be in a range offrom about 0.2 inches (about 4.9 mm) to about 0.9 inches (about 23.8mm), or more specifically about 0.4 inches (about 10.2 mm); the flangethicknesses T defined between the upper and lower surfaces of theflanges 2026 can be in a range of from about 0.010 inches (about 0.27mm) to about 0.045 inches (about 1.14 mm), or more specifically about0.02 inches (about 0.51 mm); and the width W2 of the arch centralspanning section 2030 can be in a range of from about 0.13 inches (about3.3 mm) to about 0.56 inches (about 14.3 mm), or more specifically about0.25 inches (about 6.3 mm). Other dimensions and/or ratios are withinthe scope of this disclosure.

With continued reference to FIG. 17B, the arch 2028 can have a length“L2” of about 0.7 inches (about 17.8 mm), while the tissue bridge 2020is in its relaxed state. In the relaxed state of the tissue bridge 2020,the ratio of the arch length L2 to the tissue bridge's overall length(L1 plus L2 plus L1) (i.e. L2 divided by (L1 plus L2 plus L1)) can rangeof from greater than 0.35 to less than 0.75, or more specifically can beabout 0.3. In the relaxed state of the tissue bridge 2020, the ratio ofthe arch length L2 to the flange length L1 (i.e. L2 divided by L1) canrange of from greater than 1 to less than 5, or more specifically can beabout 0.23. The ratio of the flange length L1 to the flange width W1(i.e. L1 divided by W1) can range of from greater than 0.5 to less than3, or more specifically can be about 0.77. Other dimensions and/orratios are within the scope of this disclosure.

Similarly (e.g., measuring in the same directions as indicated bylengths L1, L2, widths W1, W2 and thicknesses T designated in FIGS. 17Band 17C), the tissue bridge 2020 of the eleventh embodiment can beconfigured so that each foot pad 2024 has opposite upper and lowersurfaces that are each larger than a thickness defined between the upperand lower surfaces of the foot pad. As one example, the thicknessesdefined between the upper and lower surfaces of each foot pad 2024 canbe in a range of from about 0.01 inches (about 0.25 mm) to about 0.014inches (about 0.36 mm), or more specifically can be about 0.012 inches(about 0.3 mm). The upper and lower surfaces of each foot pad 2024 canbe at least two, several or many times larger than the thickness definedbetween the upper and lower surfaces of the foot pad. In one example,each inner sheet 2036 can be biaxially oriented polyethyleneterephthalate film having a thickness in a range of from about 0.0025inches (about 0.063 mm) to about 0.015 inches (about 0.38 mm), or morespecifically can be about 0.005 inches (about 0.13 mm). With regard tothe lengthwise and widthwise directions shown in FIG. 17B, in oneexample, for each inner sheet 2036, its length is at least twice itswidth, although there can be other ratios. A variety of otherconfigurations (e.g., dimensions and/or ratios) are within the scope ofthis disclosure.

Referring to FIG. 17B, in a top plan view of the tissue bridge 2020, theratio of the area of an outer hole 2059 (if present) to the area of theflange 2026 not counting the hole (i.e. the area of the outer hole 2059divided by the area of the flange 2026 not counting the hole) can rangeof from greater than 1 to less than 3. Other dimensions and/or ratiosare within the scope of this disclosure.

Referring to FIG. 17C, for a tissue bridge 2020 to be used on an area ofskin where skin curvature is minimal, angles “A1” between a planetangent to the top of the arch 2028 and the flanges 2026 can be within arange of from about 15 degrees to about 19 degrees, or more specificallycan be about 17 degrees, while the tissue bridge is in its relaxedstate. In another example, angles A1 can be within a range of from about7 degrees to about 27 degrees, or more specifically can be about 17degrees, while the tissue bridge is in its relaxed state. For areas ofskin with greater or lesser curvature, the angles A1 can be adjusted toobtain a desired level of skin eversion. Other angles are within thescope of this disclosure.

Referring to FIG. 17D, for each medial strut 2048, the length “L3” ofthe medial strut can be less than the length “L4” of half of the arch2028 in its relaxed state. More specifically, the ratio of the length L3of the medial strut 2048 to the length L4 of half of the arch 2028 (i.e.L3 divided by L4) can be in a range of from greater than 0.3 to lessthan one, while the tissue bridge 2020 is in its relaxed state. Otherdimensions and/or ratios are within the scope of this disclosure.

Referring to FIG. 17B, in a top plan view of the tissue bridge 2020,each of the side edges of the arch 2028 can have a radius of curvatureof about 0.375 inches (about 9.5 mm). The ratio of this radius ofcurvature of the arch 2028 to the length L3 (FIG. 17D) of the medialstrut 2048 (i.e. the radius of curvature of the arch 2028 divided by thelength L3) can range of from greater than 0.18 to less than 0.6, or morespecifically can be about 0.3. Other dimensions and/or ratios are withinthe scope of this disclosure.

Referring to FIG. 17D, the distance “D1” between adjacent ends of themedial struts 2048 can be in a range of from about 0.04 inches (about 1mm) to about 0.7 inches (about 18 mm), or more specifically can be about0.16 inches (about 4 mm). Other dimensions and/or ratios are within thescope of this disclosure.

FIGS. 18A-18D depict an applicator mechanism in the form of anapplicator tool 2080 that can be used, for example, to manipulate atissue bridge 2020 or another suitable medical article, for example aspart of a method of mounting the tissue bridge to tissue (e.g., apatient's skin), in accordance with the eleventh embodiment. Forexample, the applicator tool 2080 can include one or more parts orfeatures that can be spaced apart from one another and can be configuredto releasably engage the tissue bridge 2020. In the eleventh embodiment,the one or more parts or features of the applicator tool 2080 that areconfigured to engage the tissue bridge 2020 can comprise at least onebearing or contact surface 2082 and/or one or more catch parts 2084. Forexample, the contact surface 2082 can be positioned between the catchparts 2084. The applicator tool 2080 can further include areconfigurable frame connecting the contact surface 2082 and catch parts2084 to one another.

The frame of the applicator tool 2080 can include a reconfigurablelinkage (e.g., one or more links 2086) connecting the contact surface2082 and catch parts 2084 to one another. The frame of the applicatortool 2080 can further include one or more levers 2088 comprising and/orextending upwardly from the links 2086. The applicator tool 2080 can beconfigured so that when the bearing or contact surface 2082 facesdownwardly, the catch parts 2084 extend downwardly from the linkage(e.g., link(s) 2086), and the levers 2088 extend upwardly from thelinkage. The links 2086 and the levers 2088 can be cooperativelyconfigured so that at least portions of the catch parts 2084 move awayfrom one another, and the contact surface 2082 moves toward a lineextending from one to the other of the catch parts 2084, in response toat least portions of the levers 2088 being moved toward one another, aswill be discussed in greater detail below.

The contact surface 2082 can be a lower end face of a pivotable junction(e.g., flexible joint, living hinge (e.g., area of reduced thickness),or the like) between the links 2086. The catch parts 2084 can includeshanks 2090 extending from upper ends of the links 2086 and/or lowerends of the levers 2088. The links 2086 can be referred to as lowersections of the levers 2088. Each catch part 2084 can further include atleast one outer protrusion 2092 extending outwardly from the lower endof the shank 2090 in a direction that is crosswise to the length of theshank. The outer protrusions 2092 can face away from one another. Eachouter protrusion 2092 can be generally rectangular, and include an outertip 2091 and an engagement shoulder 2093. An acute angle can be definedbetween the engagement surfaces 2093 and the shanks 2090. The links 2086and the levers 2088 can be cooperatively configured so that the outerprotrusion 2092 move away from one another in response to at leastportions of the levers 2088 being moved toward one another.

The applicator tool 2080 can optionally include additional protrusions2095 (e.g., stabilizing and/or alignment protrusions) extendingoutwardly from opposite sides of the shanks 2090. A distance between theengagement shoulder 2093 and the most adjacent shoulders of thestabilizing and/or alignment protrusions 2095 can be about equal to, orslightly larger than, a thickness of the spanning section 2030 of thetissue bridge 2020. As another example, the distance between theengagement shoulder 2093 and the most adjacent shoulders/the lowersurfaces of the stabilizing and/or alignment protrusions 2095 can be ina range of from about 1 times to about 3.5 times the thickness of thespanning section 2030 of the tissue bridge 2020.

The links 2086 can extend obliquely, outwardly and upwardly from thecontact surface 2082 respectively to upper portions of the shanks 2090.The levers 2088 can extend obliquely, outwardly and upwardlyrespectively from upper portions of the shanks 2090.

The levers 2088 can define or comprise handles 2094. For example, in theembodiment depicted in FIGS. 18A-18D, the handles 2094 can be aninwardly recessed, arcuate and/or concave sections of the levers 2088,although differently configured handles are within the scope of thisdisclosure. As an example, FIG. 18B depicts two differently configuredhandles 2094, each having an outer stop surface 2097 extending crosswiseto the length of the applicator tool 2080 in a manner that seeks torestrict a user's fingers from inadvertently sliding downwardly out ofthe handle. The stop surface 2097 can be an upper surface of a post orother suitable protrusion. As another example, the stop surface 2097 canbe a lower portion of a concave, arcuate or otherwise suitable curvedsurface. The handles 2094 can also include, for example, knurlingconfigured in a manner that seeks to restrict a user's fingers frominadvertently sliding downwardly out of the handle. As depicted in FIGS.18A-18D, the knurling can be in the form of protrusions or hemisphericalbumps, although other features can be included for restricting a user'sfingers from inadvertently sliding downwardly out of the handle.

Optionally, the levers 2088 can be lower levers 2088 that extendobliquely upward from (e.g., from proximate) the contact surface 2082and/or catch parts 2084 to upper levers 2089. The upper levers 2089 canbe joined to one another at their upper ends. The upper connectionbetween the upper levers 2089 can be a pivotable junction (e.g.,flexible joint, living hinge (e.g., area of reduced thickness), or thelike) between the upper levers 2089. Alternatively, the upper levers2089 may be omitted.

The applicator tool 2080 can be an injection-molded, unitary (e.g.,single-piece) article formed from an injection-moldable, generallyelastic material such as, but not limited to, polycarbonate,polyethylene, or any other suitable injection-moldable material.Alternatively, the applicator tool 2080 can be made of metal, metalalloys, steel, or any other suitable materials that can allow forre-sterilization. For example, hinges (e.g., at the junctions betweenrespective portions of the levers 2088, 2089 and/or links 2086) or othersuitable connections that allow for relative movements between subpartscan be included in the applicator tools 2080, such as when theapplicator tools are made of relatively rigid materials. As additionalexamples, a variety of different linkages, levers, and handles of theapplicator tool 2088 are within the scope of this disclosure.

In accordance with examples of the eleventh embodiment depicted in FIGS.18D-20L, the tissue bridge 2020 and applicator tool 2080 arecooperatively configured so that the applicator tool can be releasablyengaged to the tissue bridge, and the applicator tool can be used tomanipulate the tissue bridge as part of a method of mounting the tissuebridge to tissue. For example, FIG. 18D depicts the bearing or contactsurface 2082 in opposing-face-to-face relation with an upper surface ofthe arch 2028, and the shanks 2090 extending through the inner holes2056. In the configuration of FIG. 18D, the outer protrusions 2092(FIGS. 18A-18C) are hidden from view within the receptacles 2052. Moregenerally, the catch parts of the applicator tool 2080 and tissue bridge2020 are respectively engaged to one another in FIG. 18D. However, avariety of differently configured catch parts are within the scope ofthis disclosure.

Referring to FIGS. 19A-19F, a method of using the applicator tool 2080to remove a tissue bridge 2020 from the tray 122 is described in thefollowing, in accordance with the eleventh embodiment. Referring to FIG.19A, initially, the applicator tool 2080 (e.g., in its undeformed or atrest configuration) can be engaged against the tissue bridge 2020 (e.g.,in its undeformed or at rest configuration) by way of relative movementcausing increased closeness between the applicator tool 2080 and thetray 122 (e.g., movement of the applicator tool toward the tissue bridgemounted on the release liner 2062 in the tray). In the eleventhembodiment, the applicator tool 2080 is elastic and, thus, biased towardits undeformed or at rest configuration.

Referring to FIGS. 19A and 19B, in response to the relative movement,the outer protrusions 2092 of the tool catch parts 2084 can enter thereceptacles 2052 by way of the inner holes 2056 (FIG. 17A). That is, theouter protrusions 2092 can enter the receptacles 2052 by travelingthrough the inner holes 2056. For example, the applicator tool 2080 canbe pushed downwardly to engage the tissue bridge 2020 in a manner sothat the outer protrusions 2092 of the tool catch parts 2084 enter thereceptacles 2052 by way of the inner holes 2056, and optionally also thetool contact surface 2082 engages, or at least becomes more proximateto, the central apex or any other suitable surface of the arch 2028. Insome embodiments, the tool contact surface 2082 may not (e.g., maynever) engage the tissue bridge 2020.

The applicator tool 2080 can be in its undeformed or at restconfiguration throughout the step of the outer protrusions 2092 of thetool catch parts 2084 entering the receptacles 2052 by way of the innerholes 2056. As another example, the distance between the tips of theouter protrusions 2092 can be greater than the distance between the holeedges 2058 (FIG. 17B) so that the protrusions outer protrusions 2092“snap” into the inner holes 2056 and/or receptacles 2052 and areoptionally releasably contained in the receptacles by way of aninterference fit, or the like. The outward movement of the outerprotrusions 2092 relative to one another associated with the “snap” isschematically represented by a pair of arrows in FIG. 19C.

In the eleventh embodiment, the inner holes 2056 are larger than theouter protrusion 2092 so that the outer protrusions can pass through theinner holes. Measuring in the same directions as indicated by widths W1,W2 in FIG. 17B, the widths of the outer protrusions 2092 (e.g., thewidths of the engagement shoulders 2093) can be within a range of fromless than about 1 times to about 0.4 times the width (or length) of theedges 2058 of the arch 2028 that partially define the inner holes 2056.

The relative movement causing increased closeness between the applicatortool 2080 and the tray 122 may be facilitated by a user manually holdingthe levers 2088 and/or handles 2094 (FIGS. 18A-18C) of the applicatortool and moving the applicator tool toward the tissue bridge 2020 in thetray, or the tissue bridge may be supported by any other suitablesurface. Referring to FIG. 19B, the outer protrusions 2092 can engagerespective surfaces of the medial struts 2048 in response to therelative movement causing increased closeness between the applicatortool 2080 and the tray 122. As a more specific example depicted in FIG.19C, the engagement shoulders or surfaces 2093 of the tool 2080 canengage the engagement surfaces or ribs 2057 of the tissue bridge 2020.

Then, for serially achieving the configurations of FIG. 19C and FIG.19D, simultaneously and/or in series, the relative movement causingincreased closeness between the applicator tool 2080 and the tray 122can continue, and the handles 2094 can be manually squeezed together(e.g., pushed toward one another) so that the applicator toolreconfigures toward its actuated or deformed configuration and appliesdeforming forces on the tissue bridge 2020. As the applicator tool 2080is, for example, simultaneously pushed with greater force against thetissue bridge 2020 and caused to deform farther toward its deformedconfiguration, the applicator tool applies forces against the tissuebridge 2020 so that the tissue bridge is responsively deformed towardits strained, deformed, or extended configuration. For example, theapplicator tool 2080 can simultaneously apply a downward force via thecontact surface 2082 and laterally outward forces via the catch parts2084.

Referring to FIG. 19C, the distance between the medial struts 2048 andthe inner holes 2056 (FIG. 17A) can be about the same as, or smallerthan, the distance between the engagement shoulders 2093 and the outertips 2091 of the outer protrusions 2092. As a result, the outerprotrusions 2092 (e.g., the outer tips 2091) can engage the medialstruts 2048 and cause them to deflect outwardly/downwardly, for exampleas shown in FIG. 19C. As another example, the distance between theengagement shoulders 2093 and the outer tips 2091 of the outerprotrusions 2092 can be in a range of from about one to two times thedistance between the medial struts 2048 and the inner holes 2056 in therelaxed configuration of the tissue bridge 2020.

Continuing to refer to FIG. 19C, as the applicator tool 2080 of theeleventh embodiment is transitioned from its undeformed or at restconfiguration (e.g., FIG. 19C) to its actuated or deformed configuration(e.g., FIG. 19E), each side of the applicator tool and the associatedtissue bridge 2020 can deform substantially symmetrically. For example,in FIG. 19C, the distance “D2” schematically depicts the span of travelof the junction between the adjacent link 2086 and shank 2090 thatoccurs during in the transition of the applicator tool 2080 from itsundeformed or at rest configuration to its actuated or deformedconfiguration, and vice versa, and the span of travel D2 can be about0.45 inches (11.5 mm). As another example, the distance “D3”schematically depicts how far the contact point or area between theengagement rib 2057 and engagement shoulder 2093 travels during in thetransition of the applicator tool 2080 from its undeformed or at restconfiguration to its actuated or deformed configuration, and vice versa,and the distance D3 can be about 2.1 inches (5.4 mm).

As schematically depicted in FIG. 19C, a side of a triangle or distance“S1” is defined between the central point of the top surface of thetissue bridge arch 2028 and the junction of the link 2086 and shank2090. A side of the triangle or distance “S2” is defined between thejunction of the link 2086 and shank 2090 and the contact point or areabetween the engagement rib 2057 and engagement shoulder 2093. An angle“A2” defined between a triangle side “S3” and triangle side S2 can beless than 120 degrees, or more specifically about 93 degrees. The ratioof the distance S1 to the distance S2 (i.e. S1 divided by S2) can rangeof from about 1.0 to about 1.4, or can range of from about 1.1 to about1.2, or more specifically can be about 1.14.

In the transition from the configuration of FIG. 19C to theconfiguration of FIG. 19D, the outer portions of the foot pads 2024 havemoved, or more specifically pivoted, away from the tray outer sections132. As discussed above, the release liner flaps 2138 can be attached tothe outer portions of the foot pads 2024 by way of the outer adhesivelayer 2042. Therefore, the flaps 2138 can be carried by, and pivot with,the outer portions of the foot pads 2024. Therefore, the flaps 2138pivot outwardly relative to a reminder of the release liner 2062 thatremains fixedly mounted to the tray base panel 2124. That is, the flaps2138 can pivot outwardly relative to (e.g., at least partiallydelaminate from) a reminder of the release liner 2062 and the tray 122in response to respective movement, reconfiguring, and/or the like ofthe tissue bridge 2020 and applicator tool 2080. In the eleventhembodiment, the release liner 2062 is a support that supports the tissuebridge 2020, and each flap 2138 can be referred to as a first section ofthe support, and the reminder of the release liner 2062 and/or the tray122 can be referred to as a second section of the support, or the like.

As another example, in the transition from the configuration of FIG. 19Cto the configuration of FIG. 19D, the outer protrusions 2092 have pushed(e.g., deflected) the medial struts 2048 downwardly toward the recessedcentral section 2130 of the tray 122. That is, in an example, the medialstruts 2048 can pivot downwardly relative to a reminder of the foot pads2024 in response to respective movement, reconfiguring, and/or the likeof the tissue bridge 2020 and applicator tool 2080.

Referring to FIG. 19C-19F, the applicator tool 2080 and tissue bridge2020 can be cooperatively configured and engaged to one another in apredetermined manner so that, in response to the handles 2094 beingmanually squeezed or pushed closer to one another, at least lowerportions of the tool catch parts 2084 are moved farther away from oneanother and the contact surface 2082 moves toward a line between thecatch parts 2084, and this movement of the applicator tool 2080 forcesthe tissue bridge 2020 into its fully deformed or extendedconfiguration, an example of which is shown in FIG. 19F. For example,the manual inward force applied to the opposite sides of the handles2094 to achieve this configuration can be in a range of from more than0.2 pounds force (0.89 newtons) to less than 2 pounds force (8.9newtons).

In the transition from the configuration of FIG. 19D to theconfiguration of FIG. 19E, the release liner 2062 typically fullyseparates from the tissue bridge 2020, and the flaps 2138 can pivot/fallback into their original positions in response to relative movementcausing increased distance between the applicator tool 2080 and the tray122. The release liner 2062 typically fully separates from the tissuebridge 2020 in a manner that fully exposes the outer adhesive layer 2042(e.g., patient contact adhesive), so that there are no remnants of therelease liner 2062 stuck to the tissue bridge and the outer adhesivelayer is ready for being used to secure the tissue bridge to tissue,such as the skin of a patient.

For example, in FIG. 19F the tissue bridge 2020 and applicator tool 2080are engaged to one another, and both the tissue bridge and theapplicator tool are in their deformed configurations so that the tissuebridge is securely grasped or otherwise held by the applicator tool, sothat as the applicator tool is manually moved away from the tray 122 theapplicator tool carries the tissue bridge away from the tray. While thetissue bridge 2020 is securely held by the applicator tool 2080, theapplicator tool can be used to apply the tissue bridge to tissue, suchas the skin of a patient.

At least FIGS. 19C-19E may be characterized as schematically depictingstretching of the release liner 2062. However, any of such stretchingcan be avoided, for example as shown in FIG. 19G, by including a line ofdisruption 2063 (e.g., cut, slit or tear line) between respectivesections of the release liner 2062. As another example depicted in FIG.19H, a length of the portion of the release liner 2062 positionedbetween the inner ends of the foot pads 2024 can be greater than thedistance between the inner ends of the foot pads 2024. The excess lengthof the portion of the release liner 2062 between the inner ends of thefoot pads 2024 can be in the form of a bulge or overlapping section ofthe release liner 2062, or the like.

Referring to FIGS. 19I-19L, a method of using the applicator tool 2080to apply a tissue bridge 2020 to tissue 2152 on either side of a cut2150 in a patient's skin 2152 is described in the following, inaccordance with the eleventh embodiment. FIG. 19I schematically depictswith dashed lines 2154 the originally spaced apart edges of the cut2150, and a solid line 2156 schematically depicts that the edges of thecut may be manually pushed together prior to applying the tissue bridge220 over the cut. The applicator tool 2080 holding the tissue bridge2020 can be moved toward the cut 2150 so that the tissue bridge 2020extends crosswise to, or more specifically substantially perpendicularto, the length of the cut 2150, and the first contact between the tissuebridge and the tissue or skin 2152 occurs at the inner end sections orportions of the medial struts 2048 on either side of the cut. Referringto FIG. 19J, the applicator tool 2080 can continue to be pushed closerto the cut 2150 so that the inner portions of medial struts 2048 beginto become adhered to the skin 152 by the outer adhesive layer 2042(e.g., patient contact adhesive). For example, the transmission of forcefrom the applicator tool 2080, by way of the catch parts 2084, againstthe medial struts 2048 can cause the pressure-sensitive adhesive layer2042 to be engaged against the tissue 2152 with sufficient force tocause the inner portions of medial struts 2048 to become adhered to thetissue 2152 at opposite sides of the cut 2150. Then, for example as atleast partially depicted in FIG. 19K, the manual force on the handles2094 of the applicator tool 2080 can be reduced, so that the tissuebridge 2020 returns toward its at rest configuration, and the medialstruts 2048 become closer together and push the portions of the tissue2152 to which they are adhered toward one another. Then, in response tothe tissue bridge 2020 returning farther toward its at restconfiguration, the reconfiguring of the tissue bridge causes the outerportions of the foot pads 2024 to move or pivot downwardly into contactwith the tissue 2152 at opposite sides of the cut 2150. In one example,this contact between the outer portions of the foot pads 2024 and thetissue 2152 at opposite sides of the cut 2150 may occur with sufficientforce to cause the pressure-sensitive adhesive layer 2042 to securelyadhere the outer portions of the foot pads 2024 to the tissue 2152 atopposite sides of the cut 2150.

In accordance with the eleventh embodiment, the inner portions of themedial struts 2048 are adhesively mounting to the tissue 2152 while thetissue bridge 2020 is in its deformed or extended configuration; andthereafter as the tissue bridge 2020 returns toward its at restconfiguration and reaches an intermediate configuration that is betweenthe extended and at rest configurations, the remainder or outer portionsof the foot pads 2024 are adhesively mounted to the tissue. When thetissue bridge 2020 is first engaged against the tissue 2152, the pointof first contact and adhesive mounting to the tissue can be at the innerend sections or portions of the medial struts 2048, and this mountingcan occur while the medial struts are being pushed downwardly by way ofthe applicator tool 2080. In the eleventh embodiment, as the deformingforce being applied on the tissue bridge 2020 by the applicator tool2080 is reduced, the medial struts 2048 move or rotate inwards, thuscentrally pulling the tissues 2152 to which they are adhesively mounted,and this action by the medial struts 2048 occurs before the outerportions of the foot pads 2024 are adhesively attached to the tissue. Atthis intermediate point, in which the medial struts 2048 are at leastpartially attached to the tissue 2152 and have moved inwards, and theouter portions of the foot pads 2024 are not yet attached to the tissue,the shear stress and/or strain on predetermined tissue (i.e., tissuethat is lateral to the lateral-most contact point between the medialstrut and the tissue) is distributed laterally and in a gradual manner.Then, when the lateral or outer portions of the foot pads 2024 arepressed down and adhered to the tissue 2152, the predetermined tissueunderneath and at the lateral edges or outer edges of the foot pads 2024is secured (e.g., adhered to the foot pads) in its state in which thestress and/or strain in the predetermined tissue is distributedlaterally and in a gradual manner, which seeks to prevent sudden, highsheer stress at the lateral edges (e.g., opposite ends) of the tissuebridge 2020.

Referring to FIG. 19L, the applicator tool 2080 can then be removed fromthe tissue bridge 2020 so that the tissue bridge remains mounted overthe cut 2150; then the applicator tool may be used to install anothertissue bridge. In addition, a user can push down manually with theirfingers 2157 on the foot pads 2024, for example with sufficient force toensure that the pressure-sensitive adhesive layer 2042 securely adheresthe foot pads 2024 to the tissue 2152 at opposite sides of the cut 2150.In accordance with the eleventh embodiment, the tissue bridge 2020 canbe mounted to the tissue 2152 in a manner such that the tissue bridgeand tissue apply force against one another, and the force applied by thetissue typically restricts the tissue bridge from fully returning to itsat rest configuration. As a result, the tissue bridge 2020 appliescompressive force to the tissue 2152 by way of the foot pads 2024 in amanner that can, for example, reduce tension in the tissue, help closethe wound 2150, help inhibit wound reopening and/or inhibit scardisfiguring (e.g., widening). In the example shown in FIG. 19l , thetissue 2152 proximate the scar and/or wound 2150 bulges into the centralarea over which the arch 2028 extends.

The tissue bridge 2020, release liner 2062 and applicator tool 2080 canbe configured differently than discussed above. For example, one or moreof the layers of the tissue bridge 2020 can be configured differentlythan discussed above. As a more specific example, in the variation ofthe tissue bridge 2020 depicted in FIGS. 20A-20D, each of the innersheets 2036 and the intermediate adhesive layers 2040 can includeopposite, outwardly extending lateral extensions 2037, 2041.Accordingly, the inner sheets 2036, the intermediate adhesive layers2040 and foot pads 2024 become wider in the inward direction, and taperin the outward direction, such the medial strut 2048 sections of thefoot pads are wider than the outer sections of the foot pads. Each ofthe outer sheets 2034 and outer adhesive layers 2042 can be generally inthe form of a quadrilateral, trapezoid, isosceles trapezoid, or anyother suitable shapes.

Referring to FIG. 20D and in an example of some versions of thisdisclosure, the release liner 2062 may not be associated with (e.g.,mounted to) any tray 122 (FIGS. 18A-18D). For example, for the versiondepicted in FIG. 20D, when the tissue bridge 2020 is fully assembled onthe release liner 2062, thereafter at least a portion of the releaseliner may be removed, and then the tissue bridge 2020 may be applied byhand (e.g., not using an applicator). In this example, a user canmanually grasp and pull a tab 2466 defined in the release liner 2062between a pair of breachable lines of disruption (e.g., tear lines). Thetab 2466 can be part of a central a central section 2462 of the releaseliner 2062 that is at least partially defined between the lines ofdisruption. Outer release liner portions 2464 can be manually graspedand used for mounting the tissue bridge 2020 to tissue.

As additional examples, FIGS. 21 and 22 depict variations of theapplicator tool 2080, wherein the outer protrusions 2092 are configureddifferently and the stabilizing and/or alignment protrusions 2095 canoptionally be omitted. For example, in FIG. 21, the engagement shoulder2093 can be at least partially defined by a bend in the shank 2090. Asanother example, in FIG. 22 the outer tip 2091 and engagement shoulder2093 are relatively rounded.

FIGS. 23A-23C depict an applicator tool 2080 in accordance with atwelfth embodiment, wherein the tissue bridge 2020 is schematicallydepicted in dashed lines in FIGS. 23B and 23C. The twelfth embodimentapplicator tool 2080 includes parts or features that are spaced apartfrom one another and configured to releasably engage the tissue bridge2020. In the twelfth embodiment, the parts or features of the applicatortool 2080 that are configured to engage the tissue bridge 2020 includebearing or contact surfaces 2082 and catch parts 2084. For example, thecontact surfaces 2082 can be positioned between the catch parts 2084.The twelfth embodiment applicator tool 2080 further includes areconfigurable frame connecting the contact surfaces 2082 and catchparts 2084 to one another.

Referring to FIG. 23A, the frame of the twelfth embodiment applicatortool 2080 include a reconfigurable linkage (e.g., links 2086A, 2086B)connecting the contact surfaces 2082 and catch parts 2084 to oneanother. The catch parts 2084 extend downwardly from the levers 2088and/or handles 2094 and/or linkage (e.g., links 2086A), and the levers2088 and/or handles 2094 extend upwardly from at least some of thelinkage. The links 2086A are connected to one another by way of one ormore additional links, for example the links 2086B, which form a hingeor hinge-like member (e.g., a pivotable junction, flexible joint, livinghinge (e.g., area of reduced thickness), or the like). The contactsurfaces 2082 can be lower surfaces of protrusions extending outwardlyfrom lower end sections of the links 2086A. The links 2086A, 2086B andlevers 2088 and/or handles 2094 can be cooperatively configured so thatat least lower portions of the catch parts 2084 move away from oneanother and the contact surfaces 2082 move toward a line extending fromone to the other of the catch parts 2084 in response to at leastportions of the levers 2088 and/or handles 2094 being moved toward oneanother.

In the version of the twelfth embodiment depicted in FIGS. 23B and 23C,the catch parts 2084 of the applicator tool 2080 are configured torespectively mate with the tissue bridge outer holes 2059 (FIG. 17A),for example as discussed above with reference to the ninth embodiment.Similarly, the lower ends of the links 2086A are configured torespectively mate with (e.g., extend into and/or through) the tissuebridge inner holes 2056 (FIG. 17A). The bearing or contact surface 2082are configured to be in opposing-face-to-face relation with (e.g.,opposing-face-to-face contact with) the upper surface of the tissuebridge arch 2028. Additionally or alternatively, lower surfaces of thelinks 2086A and/or 2086B can be configured to be inopposing-face-to-face relation with (e.g., opposing-face-to-face contactwith) the upper surface of the tissue bridge arch 2028. For example,FIGS. 24A-24C depict a thirteenth embodiment applicator tool 2080 thatis like the twelfth embodiment applicator tool, except, for example,that the bearing or contact surfaces 2082 are lower surfaces of thelinks 2086B that are configured to be in opposing-face-to-face relationwith (e.g., opposing-face-to-face contact with) the upper surface of thetissue bridge arch 2028.

FIGS. 25A-25C depict an applicator tool 2380 in receipt of a tissuebridge 2020; and FIG. 25C depicts that the engaged together applicatortool 2380 and tissue bridge 2020 are both in their deformedconfigurations so that the tissue bridge is securely grasped orotherwise held by the applicator tool, in accordance with a fourteenthembodiment. The catch parts 2384 comprise receptacles, or morespecifically inwardly open holes or slots that can be defined betweenparts, plates, slabs or other suitable features. In the fourteenthembodiment, the opposite ends of the tissue bridge 2020 respectivelyextend into the inwardly open holes or slots of the catch parts 2384.The thickness of the slots of the catch parts 2384 can be slightlylarger than the thickness of the opposite end sections of the tissuebridge 2020. The handles 2394 can be loops, partial loops, and/or othersuitable features for receiving fingers of an operator of the tool 2380,and optionally another finger can be pressed downwardly on a platformand/or other suitable features positioned along the linkage (e.g.,linkages 2186A, 1186B).

The applicator tool 2380 can have a first body comprising a first lever2388 connected to a first catch part 2384, and a second body comprisinga second lever 2388 connected to a second catch part 2384. Referring toFIGS. 25B and 25C, the reconfigurable linkage (e.g., linkages 2186A,2186B) can connect the first and second bodies to one another, and beconfigured so that (e.g., simultaneously): the first and second bodiesare pivotable relative to one another about first and second axes 2371,2372, respectively; and the first and second axes 2371, 2372 are movabletoward and away from one another.

As depicted in FIGS. 25A-25C, release or peel liner strips 2464 arerespectively mounted to the foot pads 1024 and partially positioned inthe receptacles or slots of the catch parts 2384 so that the patientcontact adhesive is restricted from adhering to the catch parts 2384.Inner ends of the release strips 2464 can include at least one foldedover flap 2465.

As depicted in FIGS. 26A-C, the central link 2186A of the applicatortool 2380 can extend upwardly from the other links 2186B. A platformand/or other suitable features at the upper end of the central link2186A can be pressed upon by a user as part of a process of deformingthe tool 2380 and tissue bridge 2020. As depicted in FIGS. 27A and 27B,at least a portion of the linkage (e.g., linkages 1186A, 1186B of FIGS.25A-26C) can be omitted. Referring to FIGS. 28A and 28B, the inner endsof the release strips 2464 can be pulled away from the inner portions ofthe foot pads 2024 to form the folded over flaps 2465. Outer endsections of the folded over flaps 2465 can be (e.g., releasably) securedto an outer surface of the applicator tool 2380 with adhesive material2381 and/or any other suitable fastening features 2381.

Referring to FIGS. 28C-29E, a method using an applicator tool 2380 toapply a tissue bridge 2020 onto tissue 2052 including a wound 2150 isdescribed in the following, in accordance with the fourteenthembodiment. Referring to FIG. 28C, the applicator tool 2380 can bedeformed or otherwise reconfigured by manually pivoting the catch parts2384 by way of the levers 2088 and/or handles 2094 and/or any outersuitable features (e.g., linkage(s)), so that deforming forces areapplied on the tissue bridge 2020. Then, referring to FIG. 28D, theinner portions of the medial struts 2048 can begin to become adhered tothe tissue 2052. After the medial struts 2048 are at least partiallyattached to the tissue 2052, and the outer portions of the foot pads2024 are not yet attached to the tissue, the lateral or outer portionsof the foot pads 2024 can be released from the catch parts 2384 so thatthe release liners 2464 are pulled off of the foot pads 2024. Thelateral or outer portions of the foot pads 2024 can be pressed down andadhered to the tissue 2052.

Referring to FIGS. 29A-29C, the trays 122, which can be configured tosupport one or more of the above discussed tissue bridges (e.g., tissuebridges 2020) can include or otherwise be associated with one or moreattachment features (e.g., fasteners, or the like) for facilitatingattachment of the trays to a wide variety of suitable supports. Forexample, the trays 122 depicted in Figs. FIGS. 29A-29C include one ormore attachment features in the form of holes 4001 that can extendthrough the tray and be configured for receiving fasteners, positionsand/or any other suitable features. The holes can extend through outerperipheral flanges or any other suitable portions of the trays 122, orthe holes or other suitable attachment features can be associated withthe trays in any other suitable manner.

Referring to FIGS. 29A, 30 and 31, attachment features in the form ofstraps 4002 with fasteners 4003 (e.g., hook and loop releasablefasteners (e.g., VELCRO) or other suitable fasteners) can extend throughthe holes 4001 and be used to mount the tray 122 to structure. Forexample, the structure can be the arm 4004 (e.g., forearm and/or wrist)of a user, so that the user's hands can remain free for other purposes,such as for using one of the above-discussed applicator tools, oranother suitable tool, to retrieve the tissue bridges 2020 from the tray122 and apply the tissue bridges accordingly. Other structures to whichthe tray 122 can be mounted include, for example, a body part of a useror a patient, surgical drapes, trays and/or any other suitablestructures. For example, the structure can be a finger or thumb of theuser, the back of a user's hand, the user's clothing or any othersuitable areas or structures.

Referring to FIG. 32, the holes 4001 or other attachment features of thetrays 122 can be used to mount the trays to other suitable supports. Forexample, FIG. 32 depicts the tray 122 with tissue bridges 2020 of FIG.30 with the fastening straps removed, wherein the tray is exploded awayfrom a mounting base 4005, in accordance with an embodiment of thisdisclosure. The mounting base 4005 can include one or more attachmentfeatures in the form of protrusions 4006 or other suitable devices forextending into the holes 4001 to at least partially secure the tray 122to the mounting base 4005. The tray 122, or the tray 122 mounted to thebase 4004, can be sat on/supported by a tray, such as the tray of a mayostand, or the like.

FIG. 33 depicts a tray 122 that is carrying a series of tissue bridges2020 and is equipped with other types of fastening straps 4002 (e.g.,elastic straps), wherein a variety of differently configured attachmentfeatures (e.g., fastening straps) and mounting bases are within thescope of this disclosure.

FIG. 34 depicts a tray 122 with tissue bridges 2020 exploded away from amounting base 4005 equipped with attachment features in the form ofclips 4007 and fastening straps 4002, in accordance with anotherembodiment of this disclosure. The straps 4002 can be configured toremovably mount the mounting base 4005 on the arm 4004 of a user, andthe clips 4007 can be configured to releasably engage edges of the tray122, or other suitable features associated with the tray, to releasablysecure the tray to the mounting base, so that the mounting base can beserially replenished with trays containing tissue bridges 2020 withouthaving to remove the mounting base from the user's arm.

As another example, FIG. 35 depicts a tray 122 with tissue bridges 2020exploded away from a mounting base 4004 equipped with adhesive material4008 and fastening straps 4002, in accordance with another embodiment ofthis disclosure. The straps 4002 can be configured to removably mountthe mounting base 4005 on the arm of a user, and the adhesive material4008 can be configured to releasably engage the tray 122 to releasablysecure the tray to the mounting base, so that the mounting base can beserially replenished with trays containing tissue bridges 2020 withouthaving to remove the mounting base from the user's arm. As depicted inFIGS. 34 and 35, the lower surface of the mounting base 4005 can beshaped to generally conform to the shape of the user's forearm, such asby having a recessed, arcuate or concave surface extending along thelength of the lower surface of the mounting base.

As additional examples, variations in the tissue bridge geometry can bealtered for different relative effects and for use on or in differentparts of the body (e.g., to compensate for different anatomicalvariations, such as different skin thicknesses, different curvatures,different orientations, different tissue qualities such as fat layerthickness or changes due to aging). For example, shoulders of the tissuebridges can be larger when it is desirable for more medial strut pushdown. As another example, the arch can be made narrower or wider, orthicker or thinner. For example, a relatively narrow arch may be usedfor thinner skin, and more vertical forces (eversion). A relativelywider arch can be used for thicker tissues, and more horizontal forces.A relatively thicker arch can be used for more tension reduction. Arelatively thinner arch can be used over bony surfaces where there ismore horizontal than vertical movement. As another example, the medialstrut can be thicker or thinner, or can flare wider past the width ofthe body. A thicker medial strut may provide more medializing, and athinner medial strut may provide more eversion. There can also bedifferent distances defined by the gap between adjacent ends of themedial struts. Additionally, there can be different overall sizes of thetissue bridges.

At least the tissue bridges would typically be sterilized prior to beingused, and any suitable sterilization may be used. As one example,packages containing one or more tissue bridges and/or applicators may beexposed to radiation (e.g., (ionizing radiation) in a manner thatsterilizes at least the tissue bridge(s) and/or applicator(s) therein.Depending upon the types of materials from which the tissue bridge(s)and/or applicator(s) are constructed, the sterilization (e.g., byexposure to radiation) may affect the properties of the materials. Inthis regard, materials from which the tissue bridge(s) and/orapplicator(s) are constructed may be selected based upon thesterilization process to which the tissue bridge(s) and/or applicator(s)may be exposed.

As further examples, the above-discussed bodies of the tissue bridgescan be constructed of formed polymers. The formed polymers can bepolymers that are shaped from a constitutive polymer material viaprocesses such as injection molding, compression molding, stamping,thermoforming, casting, and 3D printing such as fused depositionmodeling, stereolithography, selective laser printing, polyjetprocessing, digital light processing, and other processes that are knownto those of ordinary skill in the art. The formed polymers may compriseany materials suitable for the processing and application. Suchmaterials may include light, non-allergic polymers such as acrylonitrilebutadiene styrene, polyoxymethylene, polypropylene, polyethylene,polyethylene terephthalate, polycarbonate, polyamide, polylactic acid,polyvinyl chloride, polytetrafluoroethylene, polyaryletherketone,polysulfone, and others including their blends and copolymers withmodifying additives such as colorant, reinforcers, impact modifiers,heat stabilizers, and others. Such polymer can have a modulus between0.1 and 10 GPa and elongation at between 1% and 100%. As a more specificexample, the bodies of the tissue bridges can be constructed ofpolycarbonate having an elastic modulus of about 2.4 GPa and anelongation at yield of about 7%.

As other examples, the above-discussed inner layers or sheets of thefoot pads can be film layers. These film layers can be made fromextruded polymers comprising polymers such as those discussed for formedpolymers. The polymer for the film layer can have a modulus between 0.1and 10 GPa and elongation at between 1% and 100%. As a more specificexample, inner layers or sheets of the foot pads can be extrudedpolyethylene terephthalate having an elastic modulus of about 2.6 GPaand an elongation at yield about of 5%. The inner layer can be about0.005 inches thick, or about 0.007 inches thick, and its opposite sidescan be treated with Acrylic. The adhesive layer between the body and theinner layer can be a UV curable adhesive, or any other suitableadhesive.

As additional examples, the above-discussed outer layers or sheets ofthe foot pads can be fabric layers or other suitable substrates. Theselayers can produced from non-woven or woven polymers, microporous castpolymers, or other suitable substrates. The fibers for the non-woven orcast substrates can be made from polymers such as those discussed forformed polymers. The polymer for the outer layers or sheets of the footpads can have a modulus between 0.1 and 10 GPa and elongation at between1% and 100%. The apparent elastic properties of the outer layers orsheets of the foot pads can result from the diameter, density, andorientation of the fibers constituting the non-woven or non-woven orcast substrates. Generally, the resultant non-woven or cast substratelayer can have a modulus between 0.01 and 1 GPa and elongation atbetween 10% and 1000%. As a more specific example, the outer layers orsheets of the foot pads can be a breathable polyurethane substrate havean apparent elastic modulus of about 0.2 GPa and an elongation at yieldof 100%. The polyurethane substrate can allow for moisture transmission.The outer layer can be about 0.003 inches thick. In a tissue bridge,both the body and the inner sheet can have a higher modulus ofelasticity than the outer sheet. For example, in a tissue bridge, boththe body and the inner sheet can have an elastic modulus in a range offrom about two times to about forty times the elastic modulus of theouter sheet, from about five times to about thirty times the elasticmodulus of the outer sheet, from about ten times to about twenty fivetimes the elastic modulus of the outer sheet and/or any other subrangesor values therebetween. The adhesive between the inner layer and theouter layer can be can be a silicone pressure sensitive adhesive, or anyother suitable adhesive.

As an example, the release liners can be silicone release liners thatare about 0.003 inches thick. The adhesive between the outer layer andthe release liner can be an acrylic pressure sensitive adhesive, or anyother suitable adhesive. The adhesive between the outer layer and therelease liner is typically for adhering the tissue bridge to the patient(e.g., the patient-contact adhesive). The patient-contact adhesive caninclude one or more additives, for example one or more medicinalsubstances. The one or more medicinal substances in the patient-contactadhesive can include hydroquinone, sunblock, antihistamines, steroidsand/or any other suitable additives.

A variety of examples are within the scope of this disclosure, includingthe following.

Example 1

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: a body comprising a centralsection extending over an area, and flanges respectively extendingoutwardly from opposite lower sections of the central section, at leastthe central section of the body being elastically configured to bedeformed from an at rest configuration to an extended configuration, andto return toward the at rest configuration in response to being releasedfrom the extended configuration, wherein the lower sections are fartherapart from one another in the extended configuration than in the at restconfiguration, and a first of the flanges having opposite upper andlower surfaces that are each larger than a thickness defined between theupper and lower surfaces of the first flange; and a foot pad connectedto the first flange for at least partially moving with the first flange,the foot pad extending inwardly into the area over which the centralsection extends, the foot pad having opposite upper and lower surfacesthat are each larger than a thickness defined between the upper andlower surfaces of the foot pad, and the upper surface of the foot padand the lower surface of the first flange facing toward one another.

Example 2

The medical article according to Example 1, wherein: the central sectioncomprises an arch extending over the area over which the central sectionextends; the foot pad is a first foot pad; a second of the flanges hasopposite upper and lower surfaces that are each larger than a thicknessdefined between the upper and lower surfaces of the second flange; themedical article comprises a second foot pad connected to the secondflange for at least partially moving with the second flange; the secondfoot pad extends inwardly into the area over which the central sectionextends the second foot pad has opposite upper and lower surfaces thatare each larger than a thickness defined between the upper and lowersurfaces of the second foot pad, and the upper surface of the secondfoot pad and the lower surface of the second flange face toward oneanother.

Example 3

The medical article according to Example 1, wherein the body is stifferthan the foot pad.

Example 4

The medical article according to Example 1, wherein: the central sectionof the body extends at least partially around the area over which thecentral section extends, and the foot pad comprises a extensionextending inwardly into the area over which the central section extends.

Example 5

The medical article according to Example 1, the upper surface of thefoot pad is adhered to the lower surface of the first flange.

Example 6

The medical article according to Example 1, wherein the foot padcomprises: an outer sheet configured to be attached to tissue, and aninner sheet positioned between the outer sheet and the first flange,wherein the inner sheet is stiffer than the outer sheet.

Example 7

The medical article according to Example 6, wherein the outer sheet islarger than the inner sheet, and an extension of the outer sheet extendsoutwardly past an outer edge of the inner sheet.

Example 8

The medical article according to Example 1 in combination with a toolconfigured for being used to manipulate the medical article, wherein aportion of the tool extends into a space between the body and at least aportion of the foot pad.

Example 9

The medical article according to Example 1, wherein the body furthercomprises a catch part configured for interacting with a tool.

Example 10

The medical article according to Example 9, wherein: the catch partcomprises a hole extending through the body, and at least a portion ofthe foot pad extends beneath the hole.

Example 11

The medical article according to Example 9, wherein a section of thefoot pad extends: inwardly from proximate the first flange, and beneaththe catch part.

Example 12

The medical article according to Example 9, wherein the catch partcomprises a receptacle configured to receive at least a portion of atool.

Example 13

The medical article according to Example 12, wherein the body and thefoot pad are cooperatively configured to together at least partiallydefine the receptacle.

Example 14

The medical article according to Example 12, wherein: the body comprisesan arch, the arch extends partially around the area over which thecentral section extends, and the foot pad extends inwardly from thefirst flange into the area over which the central section extends to atleast partially define the receptacle.

Example 15

The medical article according to Example 14, wherein the catch partcomprises a hole that extends through the arch and is configured toreceive an end section of a tool therethrough, such that the hole is anopening of the receptacle.

Example 16

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: an arch extending over an area;a medial strut connected to the arch and extending into the area overwhich the central section extends, the medial strut comprising: an outerlayer configured to be attached to tissue, and an inner layer positionedbetween the outer layer and the arch, wherein the inner layer is stifferthan the outer layer.

Example 17

The medical article according to Example 16, wherein the inner layer hasa higher modulus of elasticity than the outer layer.

Example 18

The medical article according to Example 16, wherein the medical articlefurther comprises a release liner adhered to the medial strut.

Example 19

The medical article according to Example 16, further comprising a footplate, wherein the medial strut is connected to the arch by way of atleast the foot plate.

Example 20

The medical article according to Example 19, wherein: the medial strutis a first medial strut, the foot plate is a first foot plate, the archcomprises first and second lower sections that are opposite from oneanother, the first medial strut is connected to the first lower sectionby way of at least the first foot plate, and the medical article furthercomprises a second medial strut connected to the second lower section byway of at least a second foot plate.

Example 21

The medical article according to Example 20, further comprising a mediumconfigured to be positioned at least partially between the first andsecond medial struts.

Example 22

The medical article according to Example 21, wherein the mediumcomprises a therapeutic agent.

Example 23

The medical article according to Example 21, wherein the mediumcomprises a silicone strip.

Example 24

The medical article according to Example 21, wherein the medium ismounted to the arch.

Example 25

A tool configured for being used to manipulate a medical article, thetool comprising: first and second parts that are spaced apart from oneanother and each configured to releasably engage a medical article; areconfigurable linkage connecting the first and second parts to oneanother; and levers extending from proximate the linkage; the linkageand the levers being cooperatively configured so that at least portionsthe first and second parts are moved away from one another in responseto at least portions of the levers being moved toward one another.

Example 26

The tool according to Example 25, wherein the levers comprise handles.

Example 27

The tool according to Example 25, wherein: the first part comprises afirst catch part configured to releasably attach to a medical article,and the second part comprises a second catch part configured toreleasably attach to the medical article.

Example 28

The tool according to Example 27, wherein: each of the first and secondcatch parts comprises a shank and a protrusion extending outwardly fromthe shank; and the protrusions face away from one another.

Example 29

The tool according to Example 27, comprising a bearing surface that is:positioned between the first and second catch parts, connected to thefirst and second catch parts by the linkage, and configured to engagethe medical article while the first and second catch parts are engagedto the medical article.

Example 30

The tool according to Example 29, wherein when the bearing surface facesdownwardly:

the first and second catch parts extend downwardly from proximate thelinkage, and the levers extend upwardly from proximate the linkage.

Example 31

A tool configured for being used to manipulate a medical article, thetool comprising: a first body comprising a first lever connected to afirst part, the first part being configured to engage a first end of amedical article; a second body comprising a second lever connected to asecond part, the second part being configured to engage a second end ofthe medical article; a reconfigurable linkage connecting the first andsecond bodies to one another, the linkage being configured so that: thefirst and second bodies are pivotable relative to one another aboutfirst and second axes, respectively, and the first and second axes aremovable toward and away from one another.

Example 32

The tool according to Example 31, wherein the linkage is configured sothat simultaneously: the first and second bodies are pivotable relativeto one another about first and second axes, respectively, and the firstand second axes are movable toward and away from one another.

Example 33

The tool according to Example 31, wherein the linkage is constructed ofelastic material.

Example 34

The tool according to Example 31, wherein the levers comprise handles.

Example 35

The tool according to Example 31, wherein: the first part comprises areceptacle configured to releasably receive a first end of a medicalarticle, and the second part comprises a receptacle configured toreceive a second end of the medical article.

Example 36

The tool according to Example 35, comprising a bearing surface that iscarried by the linkage and positioned between the first and secondparts, and configured to engage the medical article while the first andsecond parts are engaged to the medical article.

Example 37

The tool according to Example 36, wherein: the first lever extendsoutwardly from the first part; and the second lever extends outwardlyfrom the second part.

Example 38

A package, comprising: a support comprising a central section and outersections respectively extending outwardly and downwardly; and a medicalarticle at least partially contained in the package and supported by thesupport, the medical article comprising a central section and foot padsrespectively extending outwardly and downwardly from opposite lowerportions of the central section of the medical article, wherein the footpads are respectively proximate the outer sections of the support, and agap is defined between at least a portion of the central section of themedical article and the central section of the support.

Example 39

The package according to Example 38, wherein the gap is configured toreceive a portion of a tool.

Example 40

The package according to Example 38, further comprising a linerpositioned between the support and the medical article, wherein: themedical article is releasably mounted to the liner, at least a portionof the liner is fixedly mounted to the support, and the liner comprisesa line of disruption for at least partially facilitating relativemovement between the medical article and the support.

Example 41

The package according to Example 40, wherein the line of disruption atleast partially defines a flap in the liner.

Example 42

The package according to Example 40, wherein at least a portion of theline of disruption is positioned beneath a foot pad of the foot pads.

Example 43

The package according to Example 38, further comprising at least onestrap configured to at least partially mount the support to a user'sarm.

Example 44

The package according to Example 43 in combination with a base, wherein:the support comprises a tray; the tray is releasably connected to thebase; and at least one strap is configured to at least partially mountthe base to the user's arm, for connecting the tray to the user's arm byway of the base.

Example 45

The package according to Example 43, wherein at least a portion of theline of disruption is positioned beneath a foot pad of the foot pads.

Example 46

A method, comprising: deforming a medical article from an at restconfiguration to an extended configuration, comprising reconfiguring atool while the tool and the medical article are engaged to one another,wherein: the tool and the medical article being engaged to one anotheris comprised of: a first part of the tool and a first part of themedical article being in engagement with one another, and a second partof the tool and a second part of the medical article being in engagementwith one another; the reconfiguring of the tool is comprised of movinglevers of the tool toward one another so that: the first and secondparts of the tool move away from one another in response to the movingof the levers of the tool toward one another, and the first and secondparts of the medical article move away from one another in response tothe first and second parts of the tool moving away from one another.

Example 47

The method according to Example 46, wherein a support, to which themedical article is mounted, at least partially delaminates in responseto at least some of the deforming of the medical article.

Example 48

The method according to Example 46, further comprising there beingrelative movement between first and second sections of a support for themedical article in response to at least some of the deforming of themedical article.

Example 49

The method according to Example 48, wherein the relative movementcomprises pivoting the first section relative to the second section.

Example 50

The method according to Example 46, further comprising unmounting themedical article from a support while the tool and the medical articleare engaged to one another, wherein at least some of the unmountingoccurs after at least some of the deforming of the medical article.

Example 51

The method according to Example 46, further comprising disengaging thetool from the medical article after the deforming of the medicalarticle, wherein the deforming of the medical article is comprised ofdeforming the medical article so that the medical article is biasedtoward the at rest configuration and reconfigures from the extendedconfiguration in response to the disengaging of the tool from themedical article.

Example 52

The method according to Example 51, further comprising, before thedisengaging of the tool from the medical article, at least partiallymounting the medical article to tissue while simultaneously: the medicalarticle is in the extended configuration, and the tool and the medicalarticle are engaged to one another.

Example 53

A method, comprising: deforming a medical article from an at restconfiguration to an extended configuration so that foot pads of themedical article are farther apart from one another in the extendedconfiguration than in the at rest configuration, wherein each of thefoot pads comprises an inner portion extending inwardly from an outerportion of the foot pad, so that the inner portions are positionedbetween the outer portions of the foot pads; adhesively mounting theinner portions to tissue while the medical device is in its extendedconfiguration; then the medial article reconfiguring from the extendedconfiguration to an intermediate configuration that is between the atrest configuration and the extended configuration; and adhesivelymounting the outer portions of the pads to the tissue while the medicaldevice is in its intermediate configuration.

Example 54

The method according to Example 53, wherein the adhesively mounting ofthe outer portions of the pads to the tissue occurs at least partiallyin response to the reconfiguring of the medial article.

Example 55

The method according to Example 53, wherein: the inner portions comprisemedial struts, and the reconfiguring from the extended configuration tothe intermediate configuration comprises the medial struts becomingcloser together and pushing portions of the tissue toward one another.

Example 56

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: an arch comprising a spanningsection positioned between opposite lower sections of the arch, wherein:the arch is configured to be deformed from an at rest configuration toan extended configuration, and in the at rest configuration, any spacebetween the lower sections of the arch is less than a space between thelower sections of the arch in the extended configuration; and foot padsrespectively connected to the lower sections of the arch for moving withthe lower sections of the arch when the arch is transitioned between theat rest and extended configurations, wherein a first foot pad of thefoot pads comprises: an outer layer configured to be attached to tissue,and an inner layer positioned between the outer layer and the arch,wherein the inner layer is stiffer than the outer layer.

Example 57

The medical article according to Example 56, wherein the inner layer hasa higher modulus of elasticity than the outer layer.

Example 58

The medical article according to Example 56, wherein the inner layer isa flange extending outwardly from the first lower section of the arch.

Example 59

The medical article according to Example 56, further comprising aflange, wherein the inner layer is positioned between the flange and theouter layer.

Example 60

The medical article according to Example 56, further comprising a footplate, wherein the inner layer is positioned between the foot plate andthe outer layer.

Example 61

The medical article according to Example 56, wherein: the spanningsection extends over an area, a medial strut extends into the area, andthe medial strut comprises at least a portion of each of the outer layerand the inner layer.

Example 62

The medical article according to Example 56, wherein: the inner layer isan intermediate layer of the first foot pad, and the first foot padfurther comprises an inner layer positioned between the intermediatelayer and the first lower section of the arch.

Example 63

The medical article according to Example 62, wherein the inner layer isa flange extending outwardly from the first lower section of the arch.

Example 64

The medical article according to Example 62, wherein: the spanningsection extends over an area, a medial strut extends into the area, andthe medial strut comprises at least a portion of each of theintermediate layer and the inner layer.

Example 65

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: a body comprising a centralsection and flanges respectively extending outwardly from opposite lowersections of the central section, so that the central section ispositioned between the flanges, wherein the body is configured to bedeformed from an at rest configuration to an extended configuration; afoot pad mounted to at least a first of the flanges for at leastpartially moving with the first flange, wherein the foot pad comprisesan outer sheet configured to be attached to tissue, and an inner sheetpositioned between the outer sheet and the first flange, wherein theinner sheet is stiffer than the outer sheet.

Example 66

The medical article according to Example 65, wherein the inner sheet hasa higher modulus of elasticity than the outer sheet.

Example 67

The medical article according to Example 65, wherein: the centralsection extends over an area, a medial strut extends into the area, andthe medial strut comprises at least a portion of each of the outer sheetand the inner sheet.

Example 68

The medical article according to Example 65, wherein: the extendedconfiguration comprises an extended configuration in which the first andsecond flanges are spaced apart by a distance, and in the at restconfiguration, any space between the first and second flanges is lessthan the space between the first and second flanges in the extendedconfiguration.

Example 69

The medical article according to Example 65, wherein: at least a portionof the body extends over and at least partially around an area, and thefoot pad comprises a extension extending inwardly into the area.

Example 70

The medical article according to Example 65, wherein an extension of theouter sheet extends outwardly past an outer edge of the inner sheet.

Example 71

The medical article according to Example 19, wherein the outer sheet islarger than the inner sheet.

Example 72

The medical article according to Example 65, wherein the foot pad is afirst foot pad, and the medical article further comprises a second footpad mounted to the second flange for moving with the second flange,wherein the second foot pad comprises an outer sheet configured to beattached to tissue, and an inner sheet positioned between the secondflange and the outer sheet of the second foot pad, wherein the innersheet of the second foot pad has a higher modulus of elasticity than theouter sheet of the second foot pad.

Example 73

The medical article according to Example 65 in combination with a toolconfigured for being used to manipulate the medical article, wherein aportion of the tool extends into a space between the body and at least aportion of the foot pad.

Example 74

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: a body comprising a centralsection, flanges respectively extending outwardly from lower portions ofthe central section, and a catch part configured for interacting with atool; and a foot pad mounted to at least a first of the flanges for atleast partially moving with the first flange, wherein a section of thefoot pad extends below the catch part and is configured for interactingwith a tool.

Example 75

The medical article according to Example 74, wherein: the catch partcomprises a hole extending through the body, and at least a portion ofthe foot pad extends beneath the hole.

Example 76

The medical article according to Example 74, wherein a section of thefoot pad extends inwardly from the first flange and beneath the catchpart.

Example 77

The medical article according to Example 74, wherein a section of thefoot pad is a medial strut.

Example 78

The medical article according to Example 74, wherein: the catch partcomprises a hole extending through the spanning section of the body, andthe section of the foot pad is a medial strut that extends beneath thehole.

Example 79

The medical article according to Example 78, wherein there is a gapbetween the hole and the medial strut.

Example 80

The medical article according to Example 74, wherein the catch partcomprises a receptacle configured to receive at least a portion of atool.

Example 81

The medical article according to Example 80, wherein the body and thefoot pad are cooperatively configured to together at least partiallydefine the receptacle.

Example 82

The medical article according to Example 80, wherein: the body comprisesan arch, the arch extends partially around an area, the foot pad extendsinwardly from the first flange into the area to at least partiallydefine the receptacle.

Example 83

The medical article according to Example 82, wherein the catch partcomprises a hole that extends through the arch and is configured toreceive an end section of a tool therethrough, such that the hole is anopening of the receptacle.

Example 84

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: an arch extending over an area;medial struts connected to the arch and extending into the area;adhesive material connected to the medial struts; and

a release liner connected to both of the medial struts by way of theadhesive material.

Example 85

The medical article according to Example 84, further comprising a firstfoot plate and a second foot plate, wherein: a first medial strut of themedial struts is connected to the arch by way of at least the first footplate; and a second medial strut of the medial struts is connected tothe arch by way of at least the second foot plate.

Example 86

The medical article according to Example 84, wherein: the release lineris a first release liner, and the medical article further comprises asecond release liner connected to the arch and extending outwardlyrelative to the first release liner.

Example 87

The medical article according to Example 86, further comprising a thirdrelease liner connected to a first lower section of the arch andextending outwardly relative to the first release liner, wherein: thefirst release liner is positioned between the second and third releaseliners, and the second release liner is connected to a second lowersection of the arch that is opposite from the first lower section of thearch.

Example 88

The medical article according to Example 87, further comprising a firstfoot plate and a second foot plate, wherein: both the third releaseliner and a first medial strut of the medial struts are connected to thefirst lower section of the arch by way of at least the first foot plate;and both the second release liner and a second medial strut of themedial struts are connected to the second lower section of the arch byway of at least the second foot plate.

Example 89

A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: an arch comprising oppositelower sections, foot pads respectively connected to the lower sections,and a medium configured to be positioned at least partially between thefoot pads and optionally comprising a therapeutic agent.

Example 90

The medical article according to Example 89, wherein the mediumcomprises a silicone strip.

Example 91

The medical article according to Example 89, wherein the medium ismounted to the arch.

Example 92

The medical article according to Example 89, wherein: each of the footpads comprises a medial strut extending into an area over which the archextends, and the medium is positioned between the medial struts.

Example 93

The medical article according to Example 89, wherein the mediumcomprises a therapeutic agent.

Example 94

The medical article according to Example 92, wherein the therapeuticagent comprises silicone.

Example 95

A tool configured for being used to manipulate a medical article, thetool comprising: first and second parts that are spaced apart from oneanother and each configured to releasably engage a medical article; areconfigurable linkage connecting the first and second parts to oneanother; and levers extending from the linkage; the linkage and thelevers being cooperatively configured so that the first and second partsare moved away from one another in response to at least portions of thelevers being moved toward one another.

Example 96

The tool according to Example 95, wherein the levers comprise handles.

Example 97

The tool according to Example 95, wherein: the first part comprises afirst catch part configured to releasably attach to a medical article,and the second part comprises a second catch part configured toreleasably attach to the medical article.

Example 98

The tool according to Example 97, wherein: each of the first and secondcatch parts comprises a receptacle for receiving a respective portion ofthe medical article.

Example 99

The tool according to Example 97, wherein: each of the first and secondcatch parts comprises a shank and a protrusion extending outwardly fromthe shank; and the protrusions face away from one another.

Example 100

The tool according to Example 97, comprising a bearing surface that ispositioned between the first and second catch parts, connected to thefirst and second catch parts by the linkage, and configured to engagethe medical article while the first and second catch parts are engagedto the medical article.

Example 101

The tool according to Example 100, wherein when the bearing surfacefaces downwardly: the first and second catch parts extend downwardlyfrom the linkage, and the levers extend upwardly from the linkage.

Example 102

A package, comprising: a support comprising a central section and outersections respectively extending outwardly and downwardly from oppositeportions of the central section; and a medical article at leastpartially contained in the package and supported by the support, themedical article comprising a central section and foot pads respectivelyextending outwardly and downwardly from opposite lower portions of thecentral section of the medical article, wherein the foot pads arerespectively proximate the outer sections of the support, and a gap isdefined between at least a portion of the central section of the medicalarticle and the central section of the support.

Example 103

The package according to Example 102, wherein the gap is configured toreceive a portion of a tool.

Example 104

The package according to Example 103, wherein: the package at leastpartially contains the tool, and the tool is configured for being usedto apply the medical article to tissue.

Example 105

The package according to Example 102, further comprising a linerpositioned between the support and the medical article, wherein: themedical article is releasably mounted to the liner, the liner is fixedlymounted to the support, and the liner comprises a line of disruption forat least partially facilitating relative movement between the medicalarticle and the support.

Example 106

The package according to Example 105, wherein the line of disruption atleast partially defines a flap in the liner.

Example 107

The package according to Example 105, wherein at least a portion of theline of disruption is positioned beneath a foot pad of the foot pads

Example 108

A method, comprising: deforming a medical article from an at restconfiguration to an extended configuration, comprising reconfiguring atool while the tool and the medical article are engaged to one another,wherein: the tool and the medical article being engaged to one anotheris comprised of: a first part of the tool and a first part of themedical article being in engagement with one another, and a second partof the tool and a second part of the medical article being in engagementwith one another; the reconfiguring of the tool is comprised of movinglevers of the tool toward one another so that: the first and secondparts of the tool move away from one another in response to the movingof the levers of the tool toward one another, and the first and secondparts of the medical article move away from one another in response tothe first and second parts of the tool moving away from one another.

Example 109

The method according to Example 108, wherein a support, to which themedical article is mounted, at least partially delaminates in responseto at least some of the deforming of the medical article.

Example 110

The method according to Example 108, further comprising there beingrelative movement between first and second sections of a support for themedical article in response to at least some of the deforming of themedical article.

Example 111

The method according to Example 110, wherein the relative movementcomprises pivoting the first section relative to the second section.

Example 112

The method according to Example 108, further comprising unmounting themedical article from a support while the tool and the medical articleare engaged to one another, wherein at least some of the unmountingoccurs after at least some of the deforming of the medical article.

Example 113

The method according to Example 108, further comprising causing theengagement between the tool and the medical article.

Example 114

The method according to Example 108, further comprising disengaging thetool from the medical article after the deforming of the medicalarticle, wherein the deforming of the medical article is comprised ofdeforming the medical article so that the medical article is biasedtoward the at rest configuration and reconfigures from the extendedconfiguration in response to the disengaging of the tool from themedical article.

Example 115

The method according to Example 114, further comprising, before thedisengaging of the tool from the medical article, at least partiallymounting the medical article to tissue while simultaneously: the medicalarticle is in the extended configuration, and the tool and the medicalarticle are engaged to one another.

Example 116

Any one or more of Example 1 through Example 115 in combination with atherapeutic agent.

Example 117

Any one or more of Example 1 through Example 116 in combination with anyone or more other of Example 1 through Example 116.

To supplement the present disclosure, this application incorporatesentirely by reference the following patent application publications:United States Patent Application Publication No. 2014/0128819, andUnited States Patent Application Publication No. 2014/0227483.

In the specification and/or figures, typical embodiments of theinvention have been disclosed. The present invention is not limited tosuch exemplary embodiments. For example, the present invention is notlimited to the specific details (e.g., dimensions and ratios) that havebeen disclosed. The use of the term “and/or” includes any and allcombinations of one or more of the associated listed items. The figuresmay be schematic representations and so are not necessarily drawn toscale. Unless otherwise noted, specific terms have been used in ageneric and descriptive sense and not for purposes of limitation.

1. A medical article for at least partially covering a wound and/or scartissue, the medical article comprising: a body comprising a centralsection extending over an area, and flanges respectively extendingoutwardly from opposite lower sections of the central section, at leastthe central section of the body being elastically configured to bedeformed from an at rest configuration to an extended configuration, andto return toward the at rest configuration in response to being releasedfrom the extended configuration, wherein the lower sections are fartherapart from one another in the extended configuration than in the at restconfiguration, and a first of the flanges having opposite upper andlower surfaces that are each larger than a thickness defined between theupper and lower surfaces of the first flange; and a foot pad connectedto the first flange for at least partially moving with the first flange,the foot pad extending inwardly into the area over which the centralsection extends, the foot pad having opposite upper and lower surfacesthat are each larger than a thickness defined between the upper andlower surfaces of the foot pad, and the upper surface of the foot padand the lower surface of the first flange facing toward one another. 2.The medical article according to claim 1, wherein: the central sectioncomprises an arch extending over the area over which the central sectionextends; the foot pad is a first foot pad; a second of the flanges hasopposite upper and lower surfaces that are each larger than a thicknessdefined between the upper and lower surfaces of the second flange; themedical article comprises a second foot pad connected to the secondflange for at least partially moving with the second flange; the secondfoot pad extends inwardly into the area over which the central sectionextends the second foot pad has opposite upper and lower surfaces thatare each larger than a thickness defined between the upper and lowersurfaces of the second foot pad, and the upper surface of the secondfoot pad and the lower surface of the second flange face toward oneanother.
 3. The medical article according to claim 1, wherein the bodyis stiffer than the foot pad.
 4. The medical article according to claim1, wherein: the central section of the body extends at least partiallyaround the area over which the central section extends, and the foot padcomprises a extension extending inwardly into the area over which thecentral section extends.
 5. The medical article according to claim 1,the upper surface of the foot pad is adhered to the lower surface of thefirst flange.
 6. The medical article according to claim 1, wherein thefoot pad comprises: an outer sheet configured to be attached to tissue,and an inner sheet positioned between the outer sheet and the firstflange, wherein the inner sheet is stiffer than the outer sheet.
 7. Themedical article according to claim 6, wherein the outer sheet is largerthan the inner sheet, and an extension of the outer sheet extendsoutwardly past an outer edge of the inner sheet.
 8. The medical articleaccording to claim 1 in combination with a tool configured for beingused to manipulate the medical article, wherein a portion of the toolextends into a space between the body and at least a portion of the footpad.
 9. The medical article according to claim 1, wherein the bodyfurther comprises a catch part configured for interacting with a tool.10. The medical article according to claim 9, wherein: the catch partcomprises a hole extending through the body, and at least a portion ofthe foot pad extends beneath the hole.
 11. The medical article accordingto claim 9, wherein a section of the foot pad extends: inwardly fromproximate the first flange, and beneath the catch part.
 12. The medicalarticle according to claim 9, wherein the catch part comprises areceptacle configured to receive at least a portion of a tool.
 13. Themedical article according to claim 12, wherein the body and the foot padare cooperatively configured to together at least partially define thereceptacle.
 14. The medical article according to claim 12, wherein: thebody comprises an arch, the arch extends partially around the area overwhich the central section extends, and the foot pad extends inwardlyfrom the first flange into the area over which the central sectionextends to at least partially define the receptacle.
 15. The medicalarticle according to claim 14, wherein the catch part comprises a holethat extends through the arch and is configured to receive an endsection of a tool therethrough, such that the hole is an opening of thereceptacle.
 16. A medical article for at least partially covering awound and/or scar tissue, the medical article comprising: an archextending over an area; a medial strut connected to the arch andextending into the area over which the arch extends, the medial strutcomprising: an outer layer configured to be attached to tissue, and aninner layer positioned between the outer layer and the arch, wherein theinner layer is stiffer than the outer layer.
 17. The medical articleaccording to claim 16, wherein the inner layer has a higher modulus ofelasticity than the outer layer.
 18. The medical article according toclaim 16, wherein the medical article further comprises a release lineradhered to the medial strut.
 19. The medical article according to claim16, further comprising a foot plate, wherein the medial strut isconnected to the arch by way of at least the foot plate.
 20. The medicalarticle according to claim 19, wherein: the medial strut is a firstmedial strut, the foot plate is a first foot plate, the arch comprisesfirst and second lower sections that are opposite from one another, thefirst medial strut is connected to the first lower section by way of atleast the first foot plate, and the medical article further comprises asecond medial strut connected to the second lower section by way of atleast a second foot plate.
 21. The medical article according to claim20, further comprising a medium configured to be positioned at leastpartially between the first and second medial struts.
 22. The medicalarticle according to claim 21, wherein the medium comprises atherapeutic agent.
 23. The medical article according to claim 21,wherein the medium comprises a silicone strip.
 24. The medical articleaccording to claim 21, wherein the medium is mounted to the arch.
 25. Amedical article for at least partially covering a wound and/or scartissue, the medical article comprising: a body comprising a centralsection extending over an area, and flanges respectively extendingoutwardly from opposite lower sections of the central section, at leastthe central section of the body being elastically configured to bedeformed from an at rest configuration to an extended configuration, andto return toward the at rest configuration in response to being releasedfrom the extended configuration, wherein the lower sections are fartherapart from one another in the extended configuration than in the at restconfiguration, and a first of the flanges having opposite upper andlower surfaces that are each larger than a thickness defined between theupper and lower surfaces of the first flange; and a foot pad connectedto the first flange for at least partially moving with the first flange,the foot pad extending inwardly towards the central section.
 26. Themedical article according to claim 25, wherein: the foot pad is a firstfoot pad; a second of the flanges has opposite upper and lower surfacesthat are each larger than a thickness defined between the upper andlower surfaces of the second flange; the medical article comprises asecond foot pad connected to the second flange for at least partiallymoving with the second flange; and the second foot pad extends inwardlytowards the central section.